Zilver Flex G18282Recalls & reported problems
Cook Ireland Ltd · Zilver Flex 35 Vascular Stent · Class 3 · Implant
Data updated Oct 13, 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 00827002182820), received between May 20, 2026 and May 20, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2026Physical Resistance/Sticking
DURING STENT DEPLOYMENT, THE PHYSICIAN OBTAINED RETROGRADE TIBI-PERONEAL ACCESS AND ATTEMPTED TO EXTEND THE STENT INTO HUNTER¿S CANAL. THE PHYSICIAN STATED ¿FELT LIKE THE STENT WASN'T FULLY OPENING" . A GUIDEWIRE COULD NOT BE ADVANCED THROUGH THE NEWLY PLACED STENT, ALTHOUGH IMAGING SUGGESTED IT WAS OPEN. MULTIPLE ATTEMPTS WERE MADE TO CROSS THE STENT, INCLUDING THE USE OF A BALLOON, WITHOUT SUCCESS. PUSHING THE STENT RESULTED IN DEFORMATION, CAUSING THE STENT TO COLLAPSE/CRUSH INTO ITSELF. THE PROCEDURE WAS DISCONTINUED, AND A SECOND PROCEDURE WAS SCHEDULED FOR TWO WEEKS LATER [(B)(6) 2026]. DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? - 6FR TERUMO SLENDER WHAT WAS THE TARGET LOCATION FOR THE STENT? - SFA (SUPERFICIAL FEMORAL ARTERY) WAS THE DEVICE USED PERCUTANEOUSLY? - YES WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? - YES WHAT WAS THE ACCESS SITE CHOSEN? - COMMON FEMORAL ARTERY WITH RETROGRADE WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? - NO DID THE PATIENT EXHIBIT DIFFICULT ANATOMY? - HEAVILY CALCIFIED WAS THE APPROACH IPSILATERAL OR CONTRALATERAL? - IPSILATERAL RETROGRADE ACCESS WHAT INTERVENTION (IF ANY) WAS REQUIRED? - ADDITIONAL PROCE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25232294 ↗
Other STENT, SUPERFICIAL FEMORAL ARTERY devices
- EverFlex™ EVD35-06-150-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 death110 reports
- SUPERA S-60-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY108 reports
- SUPERA S-55-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY88 reports
- LifeStent® Solo Vascular Stent EX062003CLBard Peripheral Vascular, Inc. · STENT, SUPERFICIAL FEMORAL ARTERY80 reports
- BioMimics 3D Vascular Stent System 144700-12Veryan Medical Limited · Stent, Superficial Femoral Artery74 reports
- SUPERA S-50-120-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY55 reports
- EverFlex™ EVD35-07-120-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
- EverFlex™ EVD35-07-060-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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