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U.S. Department of Health and Human Services

Class 1 Device Recall Zilver PTX DrugEluting Peripheral Stent

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  Class 1 Device Recall Zilver PTX DrugEluting Peripheral Stent see related information
Date Initiated by Firm April 18, 2013
Date Posted May 15, 2013
Recall Status1 Terminated 3 on December 05, 2013
Recall Number Z-1275-2013
Recall Event ID 64975
PMA Number P100022 
Product Classification Stent, superficial femoral artery, drug-eluting - Product Code NIU
Product Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile

Product Usage:
The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoropopliteal artery). The Paclitaxel coating helps prevent the artery from narrowing again (restenosis). The Zilver; PTX stent acts as a scaffold to: Hold open a narrowed artery in the thigh (femoropopliteal artery) caused by PAD. Improve blood flow to the extremity.
Code Information REF ZIV6-35-125-7-80-PTX ; UDI 10827002248950 all lots distributed through 4/16/13
Recalling Firm/
Manufacturer		 Cook, Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact B. Thomas Roberts
812-339-2235
Manufacturer Reason
for Recall		 Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events, including one death, occurred in cases where a tip separation
FDA Determined
Cause 2		 Process control
Action Cook Medical sent an Urgent Medical Device Recall letter dated April 24, 2013 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 use, quarantine, and return all affected products. Customers were asked to complete product reply form and return affected products for credit to Cook Medical, ATTN: Retrun Goods/RGA # 2013C0003. For questions contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235.
Quantity in Commerce 535 units in USA
Distribution Worldwide Distribution - USA Nationwide; in the countries of Japan, Europe, Brazil, and Australia
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = NIU and Original Applicant = Cook Ireland, Ltd.
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