Zilver Flex G61178Recalls & reported problems
Cook Ireland Ltd · Zilver Flex 35 Vascular Stent · Class 3 · Implant
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 00827002611788), received between May 11, 2026 and May 11, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
- Malposition of Device1
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.
MalfunctionMay 11, 2026Malposition of Device; Loosening of Implant Not Related to Bone-Ingrowth
CUSTOMER DEPLOYED A ZILVER FLEX STENT (B)(6) 2026) THAT ELONGATED IN THE PATIENT. STENT REMAINED IN PATIENT, DOCTOR POST DILATED WITH ON .035 BALLOON. NO ISSUES WITH BLOOD FLOW AND NO ISSUE WITH THE PATIENT. NO ADDITION PROCEDURES NECESSARY. THE FOLLOWING INFORMATION HAS BEEN RECEIVED VIA EMAIL ON 24-APR-2026. WHAT WAS THE DATE OF THE OCCURRENCE? (B)(6) 2026. IS THE DEVICE AVAILABLE FOR RETURN? NO PLEASE PROVIDE DETAILS ON WHAT TYPE OF PROCEDURE WAS PERFORMED. SFA STENTING. DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? COOK ANSEL UNSURE OF FR SIZE. WHAT WAS THE TARGET LOCATION FOR THE STENT? L SFA. WHAT DISEASE PATHOLOGY WAS BEING TREATED? PLAQUE. WAS THE DEVICE USED PERCUTANEOUSLY? N/A WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? NO WHAT WAS THE ACCESS SITE CHOSEN? PEDAL WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? YES DID THE PATIENT EXHIBIT DIFFICULT ANATOMY? NO WHAT INTERVENTION (IF ANY) WAS REQUIRED? NONE WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? NONE WAS NEEDED WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM PRIOR TO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25139544 ↗
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- 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™ EVD35-07-060-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
- EverFlex™ EVD35-07-120-120Covidien 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 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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