Zilver 518 G43771Recalls & reported problems
Cook Ireland Ltd · Zilver 518 Vascular Stent · Class 3 · Implant
All models of Zilver 518 (20)
Data updated Oct 18, 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 10827002437712), received between Jul 13, 2021 and May 29, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Off-Label Use” (2 reports).
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 18, 2026.
Most reported problems
Device problems
- Off-Label Use2
- Device Damaged Prior to Use1
- Premature Activation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2023Off-Label Use; Off-Label Use
SUPPLEMENT REPORT BEING SENT DUE TO THE COMPLETION OF THE INVESTIGATION ON 28-AUG-2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17017109 ↗MalfunctionAug 12, 2021Off-Label Use; Off-Label Use
SUPPLEMENTAL REPORT BEING SUBMITTED AS THE DEVICE WAS EVALUATED ON THE (B)(6) 2021. DEVICE EVALUATED ON (B)(6) 2021: "OUTER SHEATH SEPARATED BELOW HANDLE AT WHITE CONNECTOR CAP".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12311384 ↗MalfunctionJul 13, 2021Premature Activation; Device Damaged Prior to Use; Premature Activation; Device Damaged Prior to Use
SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO COMPLETION OF THE LAB EVALUATION ON 28-JUL-21 - "STENT PARTIALLY DEPLOYED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12156824 ↗
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
- Protégé™ GPS™ SERB65-09-60-80Ev3, Inc · STENT, ILIAC1 recall0 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C09060MLCordis US Corp. · 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
- Absolute Pro 1012536-100Abbott 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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