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FDA Gives Cook Medical's Zilver PTX Drug-Eluting Peripheral Stent a Serious Warning


5/28/2013 8:05:17 AM

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Cook Medical, Inc., Zilver PTX Drug-Eluting Peripheral Stent

Recall Class: Class I

Date Recall Initiated: April 18, 2013

Product: Zilver PTX Drug-Eluting Peripheral Stent, catalog number ZIV6-35-125-6-80-PTX

This recall includes all sizes, diameters and lot numbers prior to April 16, 2013.

Bare metal versions of Cook’s Medical Zilver Flex use a different delivery system and is not included in this recall.

The Zilver PTX Drug-Eluting Peripheral Stent was manufactured from Dec. 1, 2012 through April 16, 2013 and distributed from Dec. 13, 2012 through April 16, 2013.

Use: The Zilver PTX Drug-Eluting Peripheral Stent is a self-expanding, small metal, mesh tube with the outer surface coated with the drug Paclitaxel that is implanted in an artery of the thigh. The Paclitaxel coating helps prevents the artery from narrowing again. The Zilver PTX Drug-Eluting Peripheral Stent acts as a scaffold to hold open a narrowed artery caused by Peripheral Artery Disease in the legs and to improve blood flow.

Recalling Firm:

Cook Medical, Inc.

750 N Daniels Way

Bloomington, Indiana 47404-9102

Reason for Recall: Cook Medical received a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter. Potential adverse events that may occur in cases where the inner deliver catheter breakage occurs include possible surgery to remove the catheter tip, vascular occlusion due to an unretrieved catheter tip, thrombosis, amputation, possible cardiac arrest, and death.

Public Contact: For questions about this recall, contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235.

FDA District: Detroit District Office

FDA Comments:

On April 24, 2013, Cook Medical sent an Urgent Medical Device Recall letter to all affect customers. The letter identified the affected products, description of the problem, and actions to be taken. The letter instructed customers to:

STOP using the device;

Quarantine and return all affected products;

Complete the product reply form and return the affected products for credit to Cook Medical, ATTN: Return Goods/RGA # 2013C0003.

For questions, contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235.

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 MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.



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