Zilver 635 G43848Recalls & reported problems
Cook Ireland Ltd · Zilver 635 Vascular Stent · Class 3 · Implant
All models of Zilver 635 (55)
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 10827002438481), received between Sep 15, 2021 and Sep 15, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Off-Label Use” (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
- Off-Label Use1
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.
MalfunctionSep 15, 2021Off-Label Use; Off-Label Use
AS REPORTED TO CUSTOMER VIA PHONE CONVERSATION "DEFECTIVE" PER COMPLAINT INFORMATION RECEIVED ON 06APR2021: FORTUNATELY THE STENT WAS NOT INSIDE THE PATIENTS BODY. WE WERE ADVANCING THE STENT OVER A ROSEN WIRE, WHICH WAS FUNCTIONING WELL, WE HAD ADVANCED SEVERAL THINGS OVER IT WITHOUT ANY PROBLEMS. I DONT RECALL ANY DRIED BLOOD ON IT, I USUALLY TRY TO WIPE THE WIRE DOWN AFTER TAKING A DEVICE OFF IT. WE STARTED ADVANCING THE STENT OVER THE WIRE WHEN IT SEEMED LIKE IT WAS GETTING MORE DIFFICULT TO PUSH THE STENT OVER THE WIRE. IT SOON WOULD NOT ADVANCE OR WITHDRAW. WHILE TRYING TO PULL THE DEVICE OFF THE WIRE, THE WIRE BEGAN TO UNRAVEL. TO ANSWER THE APPLICABLE QUESTIONS. WE ACCESSED THE RIGHT GROIN TO CROSS A LEFT SFA/POPLITEAL LESION. THE ANATOMY WAS NOT TORTUOUS AND WAS FAIRLY STRAIGHT FORWARD. THE STENT DELIVERY CATHETER WAS FLUSHED AND WE DID NOT DO ANYTHING UNUSUAL WITH IT AS WE WERE TRYING TO ADVANCE IT. AFTER REMOVING THE WIRE WE HAD TO RE-CROSS THE LESION AND PLACE ANOTHER ROSEN WIRE ACROSS THE LESION, WE TOOK ANOTHER ZILVER STENT, WHICH WORKED PERFECTLY. THE STENT WAS A 6 X 80 ZILVER STENT. I DONT HAVE ANY PHOTOS OF THE STENT OR DEVICE. OFF LABEL USE: ZIV6-35-80-6-80 DEV
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12475208 ↗
Other STENT, ILIAC devices
- Cordis S.M.A.R.T. Control Vascular Stent System C10040MLCordis US Corp. · STENT, ILIAC1 recall3 reports
- Absolute Pro 1012534-100Abbott Vascular Inc. · STENT, ILIAC51 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C09060MLCordis US Corp. · STENT, ILIAC1 recall0 reports
- Protégé™ GPS™ SERB65-09-60-80Ev3, Inc · STENT, ILIAC1 recall0 reports
- Absolute Pro 1012535-100Abbott Vascular Inc. · STENT, ILIAC1 death41 reports
- Omnilink Elite 1012631-39Abbott Vascular Inc. · STENT, ILIAC27 reports
- Omnilink Elite 1012632-29Abbott Vascular Inc. · STENT, ILIAC25 reports
- Omnilink Elite 1012631-59Abbott Vascular Inc. · STENT, ILIAC21 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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