Zilver 518 G43772Recalls & 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
- 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 10827002437729), received between Dec 10, 2021 and Mar 3, 2026 — classified as 2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Off-Label Use2
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2026Off-Label Use; Difficult to Advance
AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN SFA STENTING PROCEDURE IN WHICH THE ZILVER 518 VASCULAR SELF-EXPANDING STENT, G43772, WAS USED. PHYSICIAN PERFORMED AN ATHERECTOMY WHICH WENT WELL AND REMOVED THE DEVICE USED FOR THE ATHERECTOMY. PHYSICIAN LOADED THE STENT AND WAS GOING UP AND OVER THE BIFURCATION. THE STENT GOT LOCKED ON THE WIRE AND WAS UNABLE TO ADVANCE OVER THE WIRE OR TO DEPLOY. THE DEVICES WERE REMOVED AND ANOTHER OF THE SAME ZILVER AND WIRE WAS USED TO COMPLETE THE PROCEDURE. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? - NO AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? - INSERTION/STENT PLACEMENT DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? - 6FR FLEXOR ANSEL SHEATH WHAT WAS THE TARGET LOCATION FOR THE STENT? - SFA, NOT INFORMED WHICH SIDE WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? - YES, NOTHING NOTED WAS THE DEVICE USED PERCUTANEOUSLY? - YES WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORT BEFORE THE PROCEDURE, AS PER IFU? - YES WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? - YES DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHILIC)? - NOT INFORMED-
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24496461 ↗MalfunctionDec 10, 2021Off-Label Use; Off-Label Use
COMPLETE MDR BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 07-APR-2022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12974963 ↗
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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