Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral ...
⚠ Critical Alert — Stop Using Immediately
This product has been flagged with severe risks (serious injury or death). Stop using it now and contact the brand or FDA for a refund, repair, or replacement.
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1274-2013.
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
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1274-2013.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Cook, Inc. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1274-2013.
Cook, Inc.
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Cook, Inc. Recall FAQ
Cook, Inc. is the subject of a medical implants safety report: Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral .... The notice was published on April 18, 2013 by the U.S. Food and Drug Administration (FDA). Approximately 1,057 units are potentially affected.