Zilver 518 G43786Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002437866), received between Jul 29, 2021 and Feb 8, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2024Off-Label Use; Off-Label Use

  FORESHORTENED 40 TO 30, THE DRS APPROX MEASUREMENT. PATIENT OUTCOME: NO PATIENT IMPACT REPORTED SG 12JAN2024 PATIENT/EVENT INFO - NOTES: THE FOLLOWING INFORMATION HAS BEEN RECEIVED VIA PHONE CALL ON 12JAN2024. SG 12JAN2024 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 SY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18666959 ↗
• MalfunctionJul 29, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  "INTERVENTION LCIA PREDILITATION WITH 5X40 18LP. INSERTED STENT AND WOULD NOT CROSS LESION. ANOTHER PRE-DILATION WITH A 6X40 18LP AND REINSERTED STENT BUT STILL WOULD NOT CROSS." PATIENT OUTCOME: DID ANY SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. PLEASE DESCRIBE THE OBJECT AND HOW IT WAS RETRIEVED: DID THE PATIENT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE? NO. PLEASE SPECIFY DELAY OR ANY ADDITIONAL PROCEDURE(S) AND PROVIDE DETAILS: HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12246717 ↗