FDA Device recall Z-1275-2013
Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm
- FDA Device
- Class I
- terminated
- Published 2013-05-22
On 2013-05-22 the FDA classified a Class I recall of Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm by Cook, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1275-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-04-18 |
| Published | 2013-05-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cook |
| Distribution | US |
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.
Reason
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
Identifiers
| code_info | REF ZIV6-35-125-7-80-PTX ; UDI 10827002248950 all lots distributed through 4/16/13 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1275-2013%22
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