Zilver PTX G38532Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002385327), received between Mar 3, 2017 and Nov 9, 2020 — classified as 1 injury, 2 malfunctions.
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
- Fracture1
- Off-Label Use1
- Shelf Life Exceeded1
- Use of Device Problem1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 9, 2020Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem
SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO THE INVESTIGATION BEING COMPLETED ON 17-FEB-2021.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10813834 ↗InjuryJun 27, 2018Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem
INITIAL MDR IS BEING SUBMITTED BASED ON THE REQUIREMENT FOR A SURGICAL INTERVENTION. UPON PULL BACK THE STENT BROKE, THE DOCTOR WAS ABLE TO RETRIEVE THE PORTION. AS REPORTED TO CUSTOMER RELATIONS, "UPON DEPLOYMENT THE THUMBWHEEL BROKE. A QUARTER OF THE STENT WAS IN THE DISTAL SFA AND THE THREE-QUARTERS OF THE STENT WERE IN THE DELIVERY SYSTEM AND SHEATH. UPON PULL BACK THE STENT BROKE. THE DOCTOR WAS ABLE TO RETRIEVE THE PORTION OF THE DEVICE THAT WAS IN THE DELIVERY SYSTEM AND POST-DILATED THE PART OF THE STENT THAT WAS IN THE VESSEL. IT WAS DELIVERED OVER A .018 WIRE WITH A TORTUOUS ILIAC. THE PHYSICIAN OPENED A NEW STENT AND DEPLOYED IT TO COMPLETE THE PROCEDURE."
Patient problems: Foreign Body In Patient
MAUDE report 7640550 ↗MalfunctionMar 3, 2017Shelf Life Exceeded; Shelf Life Exceeded
PROCEDURE WAS SUCCESSFUL AND WENT AS INTENDED. THE DM PROVIDED THE FACILITY WITH A PRODUCT WHICH WAS LATER FOUND TO BE EXPIRED (01/26/2017).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6375579 ↗
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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