On 7-13-2011, the FDA issued an update to warn of further complications and adverse effects connected to the transvaginal placement of surgical mesh. A previous warning was issued in 2008, but the emergence of new complications in numerous patients necessitated an official update to the original warning. The most up to date FDA warning also acknowledges that the complications associated with transvaginal mesh are not rare, which is a modification from the previous warning. The number of complaints regarding vaginal mesh almost tripled in the past 3 years, and is currently approaching a shocking 3000. Vaginal mesh has been found to expose patients to greater risk than other more traditional forms of non-mesh methods of vaginal repair. According to the FDA warning, the use of vaginal mesh is “an area of continuing serious concern.”

Vaginal Mesh Erosion Lawsuits

• ObTape Lawsuit
• Vaginal Mesh Erosion Warning by the FDA
• Bladder Sling Mesh Erosion Lawsuits
• ObTape Mesh Erosion Lawsuits
• Vaginal Mesh, Bladder Slings and ObTape Lawsuits
• Transvaginal Mesh Lawsuits

What is Vaginal Mesh?

Vaginal mesh and bladder slings along with ObTape are medical device composed of synthetic material implanted surgically for the treatment of stress urinary incontinence (SUI) and pelvic organ prolapsed (POP). Vaginal mesh treats stress urinary incontinence by supporting the urethra to prevent unexpected bladder leakage, and strengthens weakened vaginal walls for the treatment of pelvic organ prolapse. The mesh is supposed to be a permanent solution to these conditions, however for many women the distressing consequences result in further surgery for its removal. Often times, these patients were not adequately warned of the possible complications and had they been aware, they might have chosen an alternative device or treatment method. In many cases stress urinary incontinence and pelvic organ prolapsed can be treated successfully without the use of mesh. Furthermore, using vaginal mesh, bladder slings and Ob Tape can make further surgical repairs more challenging.

Vaginal Mesh Erosion

Vaginal mesh erosion happens when the vaginal mesh, bladder sling and Ob Tape actually grinds through the fragile tissue of the vaginal walls. Also referred to as extrusion or protrusion, mesh erosion is the most regular and repeatedly reported mesh-related concern. According to the FDA warning, expulsion is a complication limited to transvaginal mesh and can be avoided through the use of conventional non-mesh surgical methods. Mesh erosion can require multiple invasive surgeries to fix and can be incapacitating for some women. In a number of severe cases, multiple surgeries will not even fully resolve the complication. Other potential risks associated with vaginal mesh include, but are not limited to, pain during sexual intercourse, recurring vaginal discharge, and persistent vaginal bleeding.

Talk to a Vaginal Mesh Lawyer Today

Many patients suffering from vaginal mesh, bladder sling or Ob Tape complications wish that they had been adequately warned of the risks and potential complications before undergoing the operation. If you or a loved one is suffering from vaginal mesh injuries please call the Willis Law Firm. We have female consultants standing by, trained to discuss these sensitive issues confidentially. We are currently accepting vaginal mesh injury lawsuits nationwide. Our product liability law team at the Willis Law Firm is committed to getting you answers and financial compensation for your medical expenses, loss of income, physical pain, and emotional suffering. These cases are handled on a Contingency Fee Basis, which means that no attorney’s fees or any other expenses will be charged unless we recover for you. Call us toll free at 1-800-883-9858 for a free case evaluation about Filing a Lawsuit.

Only a week after officials in both France and Germany began restricting the prescriptions of the diabetes drug Actos made by Takeda Pharmaceuticals, the US Food and Drug Administration (FDA) will now require additional warnings that the use of Actos for more than a year might be linked with an increased risk of developing bladder cancer. Only a week prior, a French study with similar findings propelled French officials to suspend the use of Actos and officials in Germany have recommended that doctors not prescribe Actos to new patients.

The statement by the FDA is in response to a 5-year interim analysis of an ongoing 10-year study of Actos risk of bladder cancer. The FDA’s analysis claims that while they don’t see any overall increase risk of bladder cancer with the use of Actos, they noted an increased Actos bladder cancer risk among patients taking Actos for more than a year as well as those taking higher dosages of Actos. French and German studies, however, did claim that there is an overall increased risk of bladder cancer with Actos as well as an even higher risk the longer Actos is taken.

The French decision was made by its version of the FDA, the AFSSAPS which based their move on a study conducted by a national French insurer which examined results of more than 1.5 million individuals between the ages 40 and 79 years old being treated with Actos between 2006 and 2009. France’s move on Actos has triggered a study by the European Medicines agency, the umbrella drug regulatory agency of Europe. Their study is currently ongoing. A further report in an issue of Diabetes Care, reported 93 incidences of bladder cancer among Actos patients in the FDA Adverse Event Reporting system databases spanning between 2004 and 2009.

Between January 2010 and October 2010 more than 2.3 million patients filled a prescription for diabetes drug Actos. Actos has enjoyed great results following the restrictions placed on sister drug Avandia. Actos has been perceived as the ‘safer’ of the two diabetes drug, but new results linking Actos to bladder cancer might change that perception. In addition to being linked with bladder cancer, Actos has also been recently linked to increased heart failure and bone fractures.

Actos Bladder Cancer Lawsuit

If you or a family member took Takeda Pharmaceutical’s drug Actos (pioglitazone) and you have developed bladder cancer, we encourage you to contact a pharmaceutical lawyer at our firm immediately. An experienced pharmaceutical products liability lawyer at the Willis Law Firm can assist you in legal action in a potential Actos bladder cancer lawsuit against the makers of the drug.

Please fill out our online legal evaluation form to the right or call us and we will contact you within 4-12 hours for a free confidential case review. Contact our law firm immediately so that we may explain the rights and options available to you and your family.

[04/22/2011]

FDA has updated the Tysabri (natalizumab) Prescribing Information to give new information about the size of the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection, associated with use of Tysabri for the treatment of multiple sclerosis (MS) and Crohn’s disease. The update includes new safety information about patients who have taken other drugs that suppress the immune system, who may be at a higher risk for PML. Tysabri, in a class of medications called immunomodulators, has been approved by the FDA for the treatment of relapsing forms of multiple sclerosis since November 2004 and for the treatment of moderately to severely active Crohn’s disease since January 2008. The revised label includes a table summarizing rates of PML with Tysabri use according to the number of infusions (how long the drug is taken or duration of exposure) and information on a newly identified PML risk factor.

[02/05/2010]

FDA notified healthcare professionals and patients that the risk of developing progressive multifocal leukoencephalopathy (PML) increases with the number of Tysabri infusions received. This new safety information, based on reports of 31 confirmed cases of PML received by the FDA as of January 21, 2010, will now be included in the Tysabri drug label and patient Medication Guide. Information about the occurrence of immune reconstitution inflammatory syndrome (IRIS) in patients who have developed PML and subsequently discontinued Tysabri has also been added to the drug label. IRIS is a rare condition characterized by a severe inflammatory response that can occur during or following immune system recovery, causing an unexpected decline in a patient’s condition after return of immune function.

Based on the available information, FDA believes that the clinical benefits of Tysabri continue to outweigh the potential risks. Revisions to the drug label and patient Medication Guide, with the continued use of the TOUCH Prescribing Program, are intended to maximize the safe use of Tysabri and the identification of new PML cases.

Here is an important new warning about the heart drug Multaq (generic name: dronedarone), which is linked to severe liver injury. See also: Multaq Liver Failure Lawsuits,

The FDA has just classified this medication as a DO NOT USE medication.

Do not discontinue use of any medication without talking to your doctor first.

On January 14, 2011, the Food and Drug Administration (FDA) issued a safety announcement to health professionals and consumers about cases of rare, but severe liver injury in patients taking the anti-arrhythmic drug Multaq. The agency cited the cases of two patients who experienced liver failure and required liver transplants.

Then, on March 10, 2011, the maker of Multaq, Sanofi-aventis and Health Canada sent Canadian health professionals and patients much more comprehensive letters reporting that, in the 16 months from the launch of Multaq in July 2009 through November 2010, Sanofi-aventis had received 155 cases of liver injury (87 of these serious) including hepatic failure.

Read the full letters:

• Multaq FDA Warning: Multaq Dear Patient Letter
• Multaq FDA Warning: Multaq Dear Doctors Letter

What You Should Do

Sanofi-aventis provided the following guidance for consumers:

Patients need to discuss this new safety information with their healthcare professionals.

Patients should immediately report to their doctors any symptoms that suggest possible liver injury, such as “loss of appetite, nausea, vomiting, unusual tiredness, right upper stomach area pain or discomfort, yellowing of the skin or the whites of the eyes (jaundice), unusual darkening of the urine, or itching.”

Patients should discuss with their healthcare professionals the need for periodic liver function tests.

We have had previous concerns about other safety problems with Multaq. We opposed its initial approval. We are now classifying Multaq as a DO NOT USE drug. You should discuss with your health care providers what alternative medication or procedure would be best for you.

Do not discontinue use of any medication without talking to your doctor first.

Although the drug is not recommended for patients with severe heart failure, a black box warning on the label of the drug states that:

“In a placebo-controlled study in patients with severe heart failure requiring recent hospitalization or referral to a specialized heart failure clinic for worsening symptoms, patients given dronedarone [Multaq] had a greater than two-fold increase in mortality. Such patients should not be given dronedarone.”

Report any adverse effects to the FDA Medwatch program.

Here is an important new warning about the heart drug Multaq (generic name: dronedarone), which is linked to severe liver injury. See also: Multaq Liver Failure Lawsuits.

Subject: Updated Safety Information for Multaq® (dronedarone) related to liver injury

Sanofi-aventis Canada Inc., in collaboration with Health Canada would like to inform patients of new important safety information related to liver injury, reported in patients treated with Multaq. Multaq helps control abnormal heart rate and rhythm called atrial fibrillation and can lower the risk of having to go into the hospital for heart problems.

• Patients should discuss with their healthcare professionals this new safety information regarding Multaq treatment.
• Patients treated with Multaq should immediately report to their doctors symptoms possibly suggesting liver injury (such as: Loss of appetite, nausea, vomiting, unusual tiredness, right upper stomach area pain or discomfort, yellowing of the skin or the whites of the eyes (jaundice), unusual darkening of the urine, or itching) and patients should consider obtaining periodic liver function tests.

Sanofi-aventis has been working with Health Canada, and the Multaq Product Monograph was revised to include this new safety information.

Please speak with your doctor or pharmacist if you have any related concerns or if you experience any other unexpected effects while taking Multaq.

Here is an important new warning about the heart drug Multaq (generic name: dronedarone), which is linked to severe liver injury. See also: Multaq Liver Failure Lawsuits.

Subject: Updated Safety Information for Multaq® (dronedarone) in regards to hepatocellular liver injury

Dear Health Care Professional,

Sanofi-aventis Canada Inc. in collaboration with Health Canada, would like to inform you of important new safety information regarding Multaq (dronedarone).

During the 16 months following the initial launch of Multaq (July 20th, 2009), 155 post-marketing cases (87 serious cases) reporting hepatobiliary adverse events, including rare cases of hepatic failure, have been received. Some cases were suspected of drug-induced hepatic injury with a predominant hepatocellular pattern of injury, including two foreign post-marketing case reports of acute hepatic failure requiring transplantation. A definitive causal relationship between Multaq and these cases has not been established.

Exposure to Multaq through September 2010 was estimated at 79,503 patient-years.

Multaq is indicated for the treatment of patients with a history of, or current atrial fibrillation to reduce the risk of cardiovascular hospitalization due to atrial fibrillation.

• Healthcare professionals should discuss with their patients this new important safety information regarding Multaq treatment.
• Patients treated with Multaq should be advised to immediately report symptoms suggesting hepatic injury (such as anorexia, nausea, vomiting, fatigue, right upper abdominal quadrant pain, jaundice, dark urine, or itching).
• It has not been established that routine periodic monitoring of hepatic enzymes would enable early detection of severe liver injury. However, healthcare professionals should consider obtaining periodic hepatic serum enzymes, especially during the first 6 months of treatment.
• If hepatic injury is suspected, Multaq should be discontinued immediately and followed by necessary blood tests.
• The safety of restarting Multaq in patients who have sustained liver injury from any cause is unknown; accordingly, its use in such patients is not recommended.

The two cases of acute hepatic failure requiring transplantation occurred at 4.5 and 6 months after initiation of Multaq in patients with previously normal hepatic serum enzymes. Both patients were female and approximately 70 years of age.

In the first case, the patient had underlying intermittent atrial fibrillation, arterial hypertension and stable coronary artery disease. She was treated with Multaq for 4.5 months. Two weeks prior to hospitalization she reported increased exhaustion and tiredness. One week prior to admission she discontinued Multaq, and at the time of admission she was noted to have jaundice, coagulopathy, transaminitis and hyperbilirubinemia, which progressed to hepatic encephalopathy over the next nine days. A pre-transplant workup did not reveal another etiology of liver failure.

In the second case, the patient had a medical history of paroxysmal atrial fibrillation and Sjögren’s syndrome. Following 6 months of treatment with Multaq, she developed weakness, abdominal pain, coagulopathy, transaminitis and hyperbilirubinemia. She was transplanted 1 month later; no alternate etiology for liver failure was identified in the transplant work-up. In both cases, the explanted liver showed evidence of extensive hepatocellular necrosis.

Sanofi-aventis has been working with Health Canada, and the Multaq Product Monograph was revised to include this new safety information.

Darvon, Darvocet and Generic Propoxyphene Withdrawal – Risk of Cardiac Toxicity

 Sold as ISSUE: FDA notified healthcare professionals that Xanodyne Pharmaceuticals has agreed to withdraw propoxyphene, an opioid pain reliever used to treat mild to moderate pain, from the U.S. market at the request of the FDA, due to new data showing that the drug can cause serious toxicity to the heart, even when used at therapeutic doses. FDA concluded that the safety risks of propoxyphene outweigh its benefits for pain relief at recommended doses. FDA requested that the generic manufacturers of propoxyphene-containing products remove their products as well.

BACKGROUND: FDA’s recommendation is based on all available data including data from a new study that evaluated the effects that increasing doses of propoxyphene have on the heart . The results of the new study showed that when propoxyphene was taken at therapeutic doses, there were significant changes to the electrical activity of the heart: prolonged PR interval, widened QRS complex and prolonged QT interval. These changes can increase the risk for serious abnormal heart rhythms.

RECOMMENDATION: FDA recommends that healthcare professionals stop prescribing and dispensing propoxyphene-containing products to patients, contact patients currently taking propoxyphene-containing products and ask them to discontinue the drug, inform patients of the risks associated with propoxyphene, and discuss alternative pain management strategies. Patients were advised to dispose of unused propoxyphene in household trash by following the recommendations outlined in the Federal Drug Disposal Guidelines.

Darvon – Darvocet Heart Toxicity Lawyer

If you or a family member has been diagnosed with Cardiac Toxicity and been prescribed Darvon, Darvocet or generic Propoxyphene, contact our law firm to speak to a Darvon Darvocet lawyer about your legal options. Our law firm is dedicated to fighting for the rights of those that have been harmed by dangerous and recalled drugs and medical devices. For over 25 years, Attorney David Willis has been a trial lawyer representing seriously injured clients in product liability and personal injury lawsuits such as defective drug litigation, class action drug lawsuits and medical device recall lawsuits. If Darvon – Darvocet has harmed you, or a loved one, contact us right now to discuss your potential case in filing a Darvon Darvocet Heart Toxicity Lawsuit.

Inspections, Compliance, Enforcement, and Criminal Investigations

Depuy Orthopaedics, Inc. 8/19/10

Department of Health and Human Services
Public Health ServiceFood and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

WARNING LETTER

August 19, 2010

David Floyd
President
DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46582

RE: TruMatch™ Personalized Solutions System
Corail® Hip System
Refer to GEN0901195 when replying to this letter.

Dear Mr. Floyd:

The Food and Drug Administration (FDA) has learned that your firm is marketing the TruMatch™ Personalized Solutions System and the Corail® Hip System in the United States (U.S.) without the required marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed your website, www.depuyorthopaedics.com for the TruMatch™ Personalized Solutions System and the Corail® Hip System. The products are devices within the meaning of section 201(h) of the Act 21 U.S.C. § 321(h), because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.

TruMatch™

A review of our records reveals that you have not obtained marketing approval or clearance before you began offering the TruMatch™ Personalized Solutions System for sale, which is a violation of the law. Specifically, the TruMatch™ Personalized Solutions System is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for investigational device exemptions (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution. as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

Corail® Hip System

A review of our records indicates that we cleared a premarket notification (510(k)) for the Corail® Hip System, K042992, with an intended use for total hip arthroplasty “to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.” In addition, total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

The non·porous Corail AMT Hip Stem is indicated for cementless use only.

However, a brochure on your website,

http://www.depuyorthopaedics.com/HealthCare/Related%20Documents/HIPS/CEMETL

ESS%20STEMS/CORAIL%20AMT/DO Corail_AMT_ Design Rationale_ 0612-70-501r2.pdf, states the following claims about the Corail® Hip System:

• “Proprietary HA coating for initial osteointegration and fixation” (page 3);
• “Proprietary HA coating … clinically demonstrated rapid trabeculae formation leading to rapid fixation,” and “promotes osteointegration for excellent fixation” (page 4);

Promotion of this device for osseointegration (a.k.a. osteointegration), whether explicitly or implicitly (for example, through fixation claims that imply osseointegration). represent a major change or modification in the intended use of your device that require a new premarket notification. 21 CFR 807.81(a)(3)(ii). Because of these claims, the Corail® Hip System is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section, 502(o) of the Act, 21.U.S.C. 352(o), because you did not submit to FDA a notification respecting the changes to the intended use of the device, as required by section 510(k) of the Act, 21 U.S.C. 360(k), and 21 CFR 807.81(a)(3)(ii).

FDA requests that DePuy Orthopaedics, Inc. immediately cease marketing the Corail® Hip System for unapproved uses such as those described above. You should take prompt action to correct the violations listed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and lor civil money penalties.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations for the TruMatch™ Personalized Solutions System and the Corail® Hip System, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Please include in your response a list all promotional materials for the Corail® Hip System containing claims for unapproved uses such as those described above, and explain your plan for discontinuing such claims.

Your response should be sent to:

Matthew Krueger
Chief
Orthopedic and Physical Medicine Devices Branch
Office of Compliance
Center for Devices and
Radiological Health
WO 66, Room 3676
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

If you have any questions about the content of this letter please contact: Amy Skrzypchak at phone number (301) 796-5613 or amy.skrzypchak@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations by your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations, and to bring your products into compliance.

Sincerely,

/s/

Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health

******************************************

DePuy Hip Implant Attorney

If you or a loved one have been injured as the result of a DePuy Orthopaedics – Johnson & Johnson  hip replacement implant product, talk to a DePuy Hip Implant Attorney at the Willis Law Firm for legal advice about a potential DePuy hip replacement lawsuit.  Please fill out the Free Case Evaluation at the right or call us toll-free at 1-800-883-9858.

IMPORTANT NOTE: If you are required to have a revision replacement surgery to remove and replace a faulty DePuy Hip Implant, notify your doctors that you want the hip implant to be preserved as evidence and NOT shipped or returned to the manufacturer, as it is critical evidence in a potential product liability lawsuit against DePuy and Johnson & Johnson.

New safety information will be included in the Tysabri (natalizumab) drug label and patient Medication Guide: The risk of developing progressive multifocal leukoencephalopathy (PML) increases with the number of Tysabri infusions received.

PML is a rare brain infection that usually causes death or severe disability. This new safety information is based on reports of 31 confirmed cases of PML received by FDA as of Jan. 21, 2010.

The drug label will also include information about the occurrence of immune reconstitution inflammatory syndrome (IRIS) in people who developed PML and then stopped using Tysabri. IRIS is a rare but severe inflammatory response that can cause worsening of multiple sclerosis.

Tysabri is approved to treat relapsing forms of multiple sclerosis, and moderately to severely active Crohn’s disease. (PMS has not been reported in people treated with Tysabri for Crohn’s disease.)

At this time, FDA believes that the benefits of Tysabri continue to outweigh the potential risks.

Recommendation: If you take Tysabri, call your health care professional right away if you get any new or worsening medical problems (such as a new or sudden change in your thinking, eyesight, balance, or strength or other problems) that have lasted over several days.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Tysabri PML Lawyer

If you or a family member has been diagnosed with PML, or been treated with Tysabri infusions, contact our law firm to speak to a PML lawyer about your legal options. Every attorney at our law firm is dedicated to fighting for the rights of those that have been harmed by dangerous and recalled drugs and medical devices. For over 25 years, Attorney David Willis has been a trial lawyer representing seriously injured clients in product liability and personal injury lawsuits such as defective drug litigation, class action drug lawsuits and medical device recall lawsuits. If Tysabri has harmed you, or a loved one, contact us right now to discuss your potential case in filing a Tysabri PML Lawsuit with an Attorney.

Recall Class: Class I

Date Recall Initiated: November 6, 2009

Product Name: Trailblazer Support Catheter

These devices were manufactured from September 11, 2009 through September 29, 2009 and distributed from September 21, 2009 through October 27, 2009.

Use:

This catheter is a device that is introduced into a vein or artery through the skin (percutaneous) in order to guide and support a guide wire during access of blood vessels to allow wire exchanges and to provide a passage to deliver solutions to diagnose or to treat patients.

Recalling Firm:

ev3, Inc.
4600 Nathan Lane North
Plymouth, Minnesota 55442-2890

Reason for Recall:

This device may crack near the radiopaque marker band. This may result in serious patient injury, including insufficient oxygen supply to the tissues, damage to blood vessels, heart attack, limb amputation, unplanned surgery, and/or death.

Public Contact:

The company may be contacted at 1-800-716-6700, Monday – Friday, 8:00 AM – 5:00 PM, Central Time.

FDA District: Minneapolis

FDA Comments:

On November 6, 2009, the company sent a letter to their customers stating the:

• summary of the problem
• affected products
• required actions
• instructions to locate and remove all affected products

All affected products have been returned to the firm.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.