Zilver PTX G38416Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002384160), received between May 25, 2023 and Dec 10, 2025 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (4 reports).
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.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method4
- Physical Resistance/Sticking2
- Deformation Due to Compressive Stress1
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2025Failure to Advance; Deformation Due to Compressive Stress; Failure to Advance; Deformation Due to Compressive Stress
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 22-JAN-26.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23768232 ↗MalfunctionOct 14, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
PER REP - 18 SEP 2024 - ABOUT A THIRD OF THE WAY INTO DEPLOYING THE STENT, THE THUMB WHEEL BROKE AND THEN THE REST OF THE STENT CAME OUT ELONGATED AND POSSIBLY FRACTURED. THEY THEN POST-DILATED THE STENT W A 4 X 150 BALLOON. THEN THEY LAID ANOTHER 5 X 140 PTX STENT INSIDE OF IT TO REINFORCE IT. THEY THEN CONTINUED ON WITH PLACING OTHER STENTS THAT WERE ALREADY NEEDED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. WAS PATIENT HOSPITALIZED - PER REP - (B)(6) 2024 - THE PATIENT WAS ADMITTED TO STAY OVERNIGHT FOR OBSERVATION. PREFIX ZIV6-PTX/ZISV6-PTX 3.60 ARE IMAGES (E.G. ANGIOGRAPHY, US ETC.) OF THE DEVICE AND/OR PROCEDURE AVAILABLE? N/A, YES, NO -ONE PHOTO. 3.61 WAS THE DEVICE FLUSHED BEFORE THE PROCEDURE, AS PER IFU? N/A, YES, NO: YES. 3.62 WERE THERE ANY ISSUES WITH FLUSHING OF THE DEVICE? N/A, YES, NO: NO. 3.63 DETAILS OF THE ACCESS SHEATH USED (NAME, FR SIZE,LENGTH)? -6 FR DESTINATION BY 45 CM 3.64 DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHYLIC)? -.014 COMMAND WIRE 300 CM LONG AND .014 GRAND SLAM WIRE 300 CM LONG. 3.65 WHAT APPROACH WAS USED TO ACCESS THE TARGET SITE? CONTRALATERAL, IPSILATERAL, ANTEGRADE, RETROGRADE, OTHER -CONTRALATERAL AND RETROGRADE. PLEASE SPECIFY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20439210 ↗MalfunctionJul 21, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 18-JAN-2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17369574 ↗InjuryJul 18, 2023Improper or Incorrect Procedure or Method; Physical Resistance/Sticking; Improper or Incorrect Procedure or Method; Physical Resistance/Sticking
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF A LAB EVALUATION ON 18-JUL-2023. AND AN IMAGE REVIEW ON 03-AUG-2023. IMAGE REVIEW COMPLETE 03-AUG-2023. IMPRESSION: THE COMPLAINT IS PARTLY CONFIRMED. THE STENT FRACTURE IS CONFIRMED. DIFFICULTY WITH THE THUMBWHEEL CANNOT BE CONFIRMED. DELIVERY SHEATH CURVATURE WAS SEVERE. DEPLOYMENT FROM A CONTRALATERAL APPROACH AS REPORTED BY THE COMPLAINT IS DOUBTFUL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17340933 ↗InjuryJul 11, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
THE DOCTOR TRIED TO ACTIVATE THE THUMB WHEEL BUT WAS MET WITH TENSION. HE PULLED THE THUMBWHEEL BACK HARDER AND FORCED THE STENT OUT, BUT PART OF THE STENT WOULD NOT DEPLOY. THE DOCTOR PULLED THE DELIVERY SYSTEM OUT AND HALF THE STENT REMAINED IN THE BODY, THE OTHER HALF WAS STILL IN THE DELIVERY SHEATH. THE DOCTOR PLACED A COVERED STENT OVER THE FRACTURED STENT STILL IN THE BODY. I HAVE THE OTHER HALF OF THE STENT THAT WAS IN THE DELIVERY SHEATH AND CAN RETURN THE PIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17298427 ↗MalfunctionMay 25, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17001101 ↗
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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