Zilver 518 G43780Recalls & reported problems
Cook Ireland Ltd · Zilver 518 Vascular Stent · Class 3 · Implant
All models of Zilver 518 (20)
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 10827002437804), received between Feb 8, 2024 and Feb 8, 2024 — 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.
Reports received per month
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.
MalfunctionFeb 8, 2024Off-Label Use; Off-Label Use
FORESHORTENED 30 TO 20, DR MEASURED. PATIENT OUTCOME: NO PATIENT IMPACT REPORTED SG ON (B)(6) 2024. PATIENT/EVENT INFO - NOTES: THE FOLLOWING INFORMATION HAS BEEN RECEIVED VIA PHONE CALL ON (B)(6) 2024. SG (B)(6) 2024 3.32 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO 3.33 AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? REMOVING THE INTRODUCER. 3.34 DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? BMX PENUMBRA 3.35 WHAT WAS THE TARGET LOCATION FOR THE STENT? INTRACRANIAL VESSEL 3.36 WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? UNKNOWN 3.37 WAS THE DEVICE USED PERCUTANEOUSLY? YES 3.38 WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORT BEFORE THE PROCEDURE, AS PER IFU? N/A 3.39 WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? N/A 3.40 WAS POST-DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? N/A 3.41 DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYRDOPHYLLIC)? N/A 3.42 DID THE PATIENT EXHIBIT DIFFICULT OR ALTERED ANATOMY (IF ALTERED PLEASE SPECIFY HOW IT IS ALTERED)? FOCAL STENOSIS 3.43 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? NO 3.44 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18666957 ↗
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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