Zilver 518 G43793Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002437934), received between Oct 31, 2019 and Dec 13, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2023Fracture; Fracture

  AS REPORTED TO CUSTOMER RELATIONS VIA COMPLAINT EMAIL "I AM REPORTING A DEFECTIVE PRODUCT FOR UNIVERSITY OF (B)(6). THE EVENT TOOK PLACE ON 11/13 AND I WAS INFORMED ABOUT IT ON 11/16. THEY WILL NOT BE REPORTING THIS TO THE FDA, THEY DO NOT NEED A REPLACEMENT PRODUCT, YOU CAN SEND AN ACKNOWLEDGEMENT LETTER TO ME, AND I¿LL FORWARD IT ON TO THE ACCOUNT. THE PRODUCT IS NOT AVAILABLE FOR RETURN. (B)(6) G43798/C2073988 PHYSICIAN: DR. (B)(6). DESCRIPTION: ¿THE STENT BROKE¿ IF YOU CAN SEND ME THE FOLLOW-UP QUESTIONS, I WILL ASK THE CUSTOMER. I WAS NOT GIVEN MUCH DETAIL ABOUT THIS INCIDENT. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A, YES, NO AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? UNPACKING OR PREPARATION OF THE DEVICE, INSERTION, STENT PLACEMENT, REMOVING THE INTRODUCER. DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? WHAT WAS THE TARGET LOCATION FOR THE STENT? WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? N/A, YES, NO WAS THE DEVICE USED PERCUTANEOUSLY? N/A, YES, NO WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORT BEFORE THE PROCEDURE, AS PER IFU? N/A, YES, NO WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? N/A, YES, NO WAS POST-DI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18319680 ↗
• MalfunctionFeb 27, 2020Use of Device Problem; Use of Device Problem

  THIS FOLLOW UP IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION. THE DELIVERY SYSTEM WAS ADVANCED FROM THE RADIAL ARTERY TO THE ILIAC ARTERY. HOWEVER, BECAUSE TORTUOSITY OF THE DESCENDING AORTA PREVENTED IT FROM ADVANCEMENT, IT COULD NOT REACH TO THE TARGET ILIAC ARTERY AND THE STENT COULD NOT BE PLACED. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER TREATMENT. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9763711 ↗
• MalfunctionOct 31, 2019Use of Device Problem; Use of Device Problem

  DISTAL RADIAL APPROACH WAS GAINED. COMMAND WIRE GUIDE / ABBOTT AND PARENT PLUS 45 SHEATH / MEDIKIT WERE INSERTED AND THEN, ZIV5-18-125-10-80/ LOT C1309827 ADVANCED OVER THE WIRE GUIDE. DURING THE ADVANCEMENT, THE USER FELT RESISTANCE AND SUSPECTED STUCK OF DELIVERY SYSTEM. THE USER REMOVED THE DELIVERY SYSTEM AND THE WIRE GUIDE TOGETHER FOR PATIENT'S SAFETY. ANOTHER DEVICE WAS USED INSTEAD. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9261133 ↗