Zilver 635 G43857Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002438573), received between Jun 12, 2018 and Oct 11, 2018 — classified as 2 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.
Most reported problems
Device problems
- Activation, Positioning or Separation Problem1
- Delivery System Failure1
- Off-Label Use1
- Use of Device Problem1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 11, 2018Use of Device Problem; Activation, Positioning or Separation Problem; Use of Device Problem; Activation, Positioning or Separation Problem
AS REPORTED TO CUSTOMER RELATIONS, "PHYSICIAN NOTED THAT THE DEVICE LOOKED SHORTER THAN EXPECTED UNDER FLUOROSCOPY UPON DEPLOYMENT."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7955428 ↗MalfunctionJun 12, 2018Off-Label Use; Delivery System Failure; Off-Label Use; Delivery System Failure
AS REPORTED TO CUSTOMER RELATIONS: "STENT FAILED TO DEPLOY. ON SECOND DEVICE ATTEMPT (G43857, FROM LOT # C1354628), SAME DIFFICULTIES OCCURRED BUT THE PHYSICIAN WAS STILL ABLE TO ULTIMATELY DEPLOY THE STENT. STENT OUTER CATHETER DETACHED FROM THE HUB. MANAGED TO HOLD ONE OF THEM BY HOLDING BLUE OUTER CATHETER TO THE HUB. RETRIEVED SYSTEM OF 2ND DEVICE AS WELL, AND BOTH SYSTEMS ARE AVAILABLE FOR RETURN."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7590740 ↗
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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