Reported May 22, 2013 · Terminated
Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug…
Cook, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook, Inc. · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
- Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx
- Sterile Product UsageThe 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 Preven 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
- Lot codes and dates
- REF ZIV6-35-125-6-80-PTX ; REFG24890 UDI 10827002248905 All lots distributed prior to 4/16/2013
- Amount recalled
- 1,057 units in USA
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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
Using this product could cause serious injury, illness or death — stop using it now.
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