CLASS I Device recall · Reported 22 May 2013 · FDA Enforcement Report
Zilver¿ PTX¿ Drug-Eluting Peripheral Stent -;, Rx, Sterile recalled
Cook is recalling Zilver¿ PTX¿ Drug-Eluting Peripheral Stent -;, Rx, Sterile, distributed nationwide in the US. The recall was initiated on 18 Apr 2013 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1274-2013
- FDA event ID
- 64975
- Recalling firm
- Cook, Bloomington, IN
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 18 Apr 2013
- FDA classified
- 15 May 2013
- Reported
- 22 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 18 Apr 2013 | Recall initiated by company | |
| 15 May 2013 | Classified by FDA | +27 days |
| 22 May 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 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 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.
Where it was distributed
Worldwide Distribution - USA Nationwide; in the countries of Japan, Europe, Brazil, and Australia
Questions about this recall
Is Zilver¿ PTX¿ Drug-Eluting Peripheral Stent -;, Rx, Sterile recalled?
Yes. Cook recalled Zilver¿ PTX¿ Drug-Eluting Peripheral Stent -;, Rx, Sterile on 18 Apr 2013. The recall is Class I and its status is Terminated. Recall number Z-1274-2013.
Why was it 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
Which lots are affected?
REF ZIV6-35-125-6-80-PTX ; REFG24890 UDI 10827002248905 All lots distributed prior to 4/16/2013
Where was it sold?
Worldwide Distribution - USA Nationwide; in the countries of Japan, Europe, Brazil, and Australia
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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