Zilver 518 G36047Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002360478), received between Aug 13, 2019 and Oct 8, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionOct 8, 2020Off-Label Use; Material Separation; Off-Label Use; Material Separation

  DEVICE EVALUATED 09-OCT-2020. "OUTER SHEATH AT WHITE CAP ON DISTAL END OF HANDLE -SEPARATED". UPDATING PRECEDENCE TO "FLEXOR BREAKING(INC FLEXOR/HANDLE SEPARATION). FOLLOW UP REPORT TO BE SUBMITTED. WHEN DEPLOYING THE STENT THE DELIVERY CATHETER SHEATH SEPARATED FROM THE HUB. THEY WERE ABLE TO DEPLOY THE DEVICE WITH THE SHEATH BY HOLDING IT IN POSITION. PROCEDURE COMPLETED SUCCESSFULLY. THE FOLLOWING HAS BEEN ANSWERED VIA PHONE CALL- (B)(6) 14SEP2020. 1.1 GENERAL QUESTIONS FOR COMPLAINT OCCURRING DURING USE, REQUEST THE FOLLOWING: 1.2 WHERE WAS THE ACCESS SITE? LEFT FEMORAL. 1.3 WHAT WAS THE PATIENT¿S ANATOMY? I.E. SCARRED, TORTUOUS, CALCIFIED, ETC. NONE NOTED AT THE ACCESS SITE. 1.4 WHAT WAS THE TARGET LOCATION FOR THE STENT? RIGHT POPLITEAL ARTERY. WAS THE TARGET LOCATION SEVERELY CALCIFIED OR TORTUOUS? YES, IT WAS A TIGHT STENOSIS. 1.5 WAS THE DEVICE FLUSHED PRIOR TO USE? YES. 1.6 WERE THERE ANY DIFFICULTIES DEPLOYING THE STENT? YES . 1.7 WAS THE STENT FULLY DEPLOYED BEFORE REMOVING THE DELIVERY SYSTEM FROM THE PATIENT? YES. 1.8 WHAT OTHER DEVICES WERE USED IN THE PROCEDURE? A MEDTRONIC EVERFLEX THAT WAS TRIED USING BEFORE THAT WOULDN'T CROSS. THE WIRE WAS A HYDRO ST AND THE SHE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10652777 ↗
• MalfunctionAug 13, 2019Fracture; Fracture

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: THIS DEVICE WAS RECEIVED WITH THE DEVICE FROM PR266227. PER COOK INCORPORATED LAB STAFF IT APPEARS THAT THE SHEATH IS SEPARATED FROM THE HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8888143 ↗