Zilver PTX Drug-Eluting Peripheral Stent — Class I medical device recall Z-1275-2013
Terminated recall by Cook, Inc., reported 2013-05-22, distributed nationwide. Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-
| Recall number | Z-1275-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook, Inc., Bloomington, IN, United States |
| Recall initiated | 2013-04-18 |
| Classified | 2013-05-15 |
| Reported by FDA | 2013-05-22 |
| Terminated | 2013-12-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, JP |
| Quantity | 535 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10827002248950 |
| Model numbers | ZIV6-35-125-7-80-PTX |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1275-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.