Zilver PTX G38518Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002385181), received between Aug 9, 2018 and Aug 9, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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
- Activation, Positioning or Separation Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 9, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿THUMB-WHEEL MALFUNCTIONS DURING DEPLOYMENT¿ AND "STENT COMPRESSION DURING DEPLOYMENT". AS REPORTED TO CUSTOMER RELATIONS, "FISTULA STENOSIS. PATIENT HAD REOCCURRING STENOSIS AND NOT RESPONDING TO ANGIOPLASTY. PHYSICIAN REQUESTED STENTS FOR BETTER RESULTS. THE STENT DEPLOYED WITH DIFFICULTY. WHILE THEY WERE MOVING THE THUMB-WHEEL, THEY COULD NOT SEE THE STENT BEING DEPLOYED. THE STENT FINALLY DEPLOYED AFTER SEVERAL ACTIONS ON THE THUMB-WHEEL. ONCE DEPLOYED, A SEGMENT IN THE STENT WAS NOT FULLY STRETCHED OUT".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7766446 ↗
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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