Class I Medical Device Recall: ev3 NanoCross .014 OTW PTA Dilatation Catheter

Recall Class: Class I

Date Recall Initiated: November 10, 2010

Product: NanoCross .014″ PTA Balloon Catheter

Manufacturing From: May 27, 2010 – October 18, 2010

Distribution From: June 8, 2010 – November 4, 2010

The following model and lot numbers affected can be found using the following List Number Configurations:

Use: The NanoCross 0.014” OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries. It is also used for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The NanoCross Dilatation Catheter is not an implant. It is removed and discarded after the procedure is completed.

Recalling Firm:

ev3
4600 Nathan Ln N
Plymouth, Minnesota 55442-2890

Reason for Recall: There is potential for cracking or breaking during use. Cracking or breaking of the catheter shaft can result in the inability to inflate or deflate the balloon, and can result in separation of catheter components and potential embolization catheter fragments. Catheter failure may lead to unplanned intravascular or open surgery, significant vasospasm, prolonged tissue ischemia, injury, infarct, bleeding and/or death.

Public Contact: Questions should be directed to ev3 at 763-398-7000.

FDA District: Minneapolis

FDA Comments:

In a letter dated November 10, 2010, ev3 notified healthcare facilities of the NanoCross .014” OTW PTA Dilatation Catheters voluntary recall. In this letter, it was requested that all affected products are located and removed from use. Detailed steps were also provided about the return and disposition of these affected products to ev3.

Class I 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 they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

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