Trailblazer Support Catheter Class I Recall

January 5, 2010

Recall Class: Class I

Date Recall Initiated: November 6, 2009

Product Name: Trailblazer Support Catheter

Model Numbers	Lot Numbers
SC-014-135, SC-018-090, SC-035-065, SC-035-135, SC-014-150, SC-018-150, SC-035-090, SC-035-150.	7828282, 7792290, 7792584, 7805570, 7805797, 7806392, 7820252, 7790666, 7791887, 7803307, 7835331, 7822400, 7822593, 7800446, 7800555, 7800756, 7800779, 7800809, 7801822, 7801875, 7803305, 7803306, 7820273, 7834779, 7834845, 7824905, 7832205.

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.