Zilver 635 G43832Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002438320), received between Jun 12, 2017 and May 21, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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
- Activation, Positioning or Separation Problem1
- Break1
- Off-Label Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2024Off-Label Use; Off-Label Use
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON THE 18-JUN-2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19359410 ↗MalfunctionJan 10, 2024
STENT MALFUNCTIONED, FAILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18484252 ↗MalfunctionJun 12, 2017Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem
AN ATTEMPT WAS MADE TO DEPLOY THE ZILVER 635 VASCULAR SELF-EXPANDING STENT. AS THEY WERE PULLING BACK THE HANDLE ON THE DELIVERY SYSTEM, THE SHEATH DID NOT RETRACT OVER THE STENT. THE FLARED PART OF THE SHEATH SEPARATED FROM THE PLASTIC DELIVERY HUB. THE DEVICE WAS REMOVED, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6633311 ↗
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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