Zilver Flex G18239Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002182394), received between Jul 9, 2019 and Jul 9, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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.
Most reported problems
Device problems
- Fracture1
Patient problems
- Occlusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2019Fracture; Fracture
1 AUG 2012:ZFV6-35-80-7-40 (C773053) WAS PLACED ON THE PATIENT'S LEFT UPPER SFA. (B)(6) 2013:TYPE I STENT FRACTURE AT THE MIDDLE OF THE FLEX STENT WAS OBSERVED BY THE X-RAY. ADDITIONAL TREATMENT AGAINST FRACTURE WAS NOT PERFORMED. AT FIVE YEARS FOLLOW UP: IT WAS PERFORMED THE ASSESSMENT OF LEFT LEG. WAIT-AND-SEE APPROACH WAS TAKEN. THERE WAS NO OBSERVATION OF WORSEN STENT FRACTURE. [NOTE FROM CA/CJ]: THIS PATIENT HAS BEEN TREATED WITH 1X FLEX ON UPPER FSA AND 2X PTX ON LOWER SFA WITH OVERLAP. WHEN PTX STENT FLACTURE WAS REPORTED, THE PHYSICIAN CONFOUND PTX AND FLX AND WAS ABSENT TO REPORT. ADDITIONAL TREATMENT AGAINST FRACTURE WAS NOT PERFORMED THE IMAGE WILL NOT BE AVAILABLE. THERE WAS NO VESSEL TORTUOUSY.
Patient problems: Occlusion
MAUDE report 8771352 ↗
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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