Zilver PTX Drug-Eluting Peripheral Stent recall
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…
Why was Zilver PTX Drug-Eluting Peripheral Stent recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF ZIV6-35-125-7-80-PTX ; UDI 10827002248950 all lots distributed through 4/16/13
- 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…
- Recalling firm
- Cook, Inc.
- Quantity
- 535 units in USA
- Distribution
- Worldwide Distribution - USA Nationwide; in the countries of Japan, Europe, Brazil, and Australia
- Recall date
- May 22, 2013
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)