Zilver PTX G24891Recalls & reported problems
Cook Ireland Ltd · Zilver PTX, Drug-Eluting Peripheral Stent · Class 3 · Implant
All models of Zilver PTX (28)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002248912), received between Nov 20, 2014 and Nov 20, 2014 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Thrombosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 20, 2014Insufficient Device Problem Information
THE PT HAD TWO ZILVER PTX STENTS IMPLANTED ON (B)(6) 2014. THE IMPLANT PROCEDURE APPEARED TO HAVE GONE WELL AND THE STENTS LOOKED GREAT AT IMPLANT. ON (B)(6) 2014, THE PT CAME BACK TO THE HOSPITAL AS BOTH STENTS WERE ACUTELY THROMBOSED. A SECOND PROCEDURE WAS PERFORMED ON (B)(6) 2014 WITH A LASER TO OPEN UP THE STENTS. THE PHYSICIAN DOES NOT KNOW EXACTLY WHY THE STENTS THROMBOSED, BUT DID MENTION THAT THE PT POTENTIALLY MAY HAVE NOT BEEN ADEQUATELY ANTICOAGULATED. NO FURTHER ADVERSE EFFECTS TO THE PT HAVE BEEN REPORTED AS OCCURRING. REF ALSO RELATED REPORT 3001845648-2014-00249.
Patient problems: Thrombosis
MAUDE report 4283364 ↗
Other Stent, superficial femoral artery, drug-eluting devices
- ELUVIA™ H74939294601210Boston Scientific Corporation · Stent, superficial femoral artery, drug-eluting1 death80 reports
- Zilver PTX G24890Cook Ireland Ltd · Stent, superficial femoral artery, drug-eluting1 recall24 reports
- ELUVIA™ H74939294701210Boston Scientific Corporation · Stent, superficial femoral artery, drug-eluting58 reports
- Zilver PTX G38482Cook Ireland Ltd · Stent, superficial femoral artery, drug-eluting57 reports
- Zilver PTX G24895Cook Ireland Ltd · Stent, superficial femoral artery, drug-eluting1 recall3 reports
- ELUVIA™ H74939294601510Boston Scientific Corporation · Stent, superficial femoral artery, drug-eluting50 reports
- Zilver PTX G38483Cook Ireland Ltd · Stent, superficial femoral artery, drug-eluting32 reports
- ELUVIA™ H74939294701510Boston Scientific Corporation · Stent, superficial femoral artery, drug-eluting31 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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