Zilver 518 G43781Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002437811), received between Jul 12, 2017 and Apr 23, 2021 — classified as 4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2021Off-Label Use; Off-Label Use

  AS REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION "WHERE THE DEPLOYMENT HANDLE MEETS THE SHEATH THERE IS A PLATIC PIECE, ITS THIS PLASTIC PIECE THAT CAME APART CAUSING THE DEPLOYMENT HANDLE TO FREE-FLOAT. THUS, THE STENT COULD NOT BE DEPLOYED. A NEW G43781-ZIV5-18-125-8-40 WAS OPENED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY." DID ANY UNINTENDED 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. GENERAL QUESTIONS FOR COMPLAINT OCCURRING DURING USE, REQUEST THE FOLLOWING: WHERE WAS THE ACCESS SITE? - COMMON FERMORAL ARTERY WHAT WAS THE PATIENT¿S ANATOMY? I.E. SCARRED, TORTUOUS, CALCIFIED, ETC. - NONE REPORTED WHAT WAS THE TARGET LOCATION FOR THE STENT? - SUPERFICIAL FEMORAL ARTERY WAS THE TARGET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11715759 ↗
• MalfunctionDec 29, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION INTO THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. AS REPORTED TO CUSTOMER RELATIONS: "WHEN THE DR. UNLOCKED THE DEVICE THE ZILVER 518 VASCULAR SELF-EXPANDING STENT STARTED TO DEPLOY INSIDE THE 6FR SHEATH. THE STENT DID NOT DEPLOY INSIDE THE PATIENT. THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED FOR THE PROCEDURE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7153773 ↗
• MalfunctionAug 4, 2017Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  PATIENT'S ANATOMY WAS TORTUOUS. OTHER DEVICES, A GUIDING SHEATH AND 0.014" WIRE GUIDE, WERE ADVANCED BY RADIAL APPROACH AND A BALLOON DEVICE COULD ALSO ADVANCE TO THE TARGET SITE PRIOR TO INSERTION OF DELIVERY SYSTEM OF STENT. THE FIRST STENT WAS PLACED SUCCESSFULLY, BUT THE DELIVERY SYSTEM OF THE SECOND STENT (= COMPLAINT DEVICE) COULD NOT ADVANCE TO THE TARGET SITE DUE TO THE EDGE OF THE FIRST STENT AND TORTUOUS ANATOMY. THEN, THE PHYSICIAN DECIDED NOT TO PLACE ADDITIONAL STENT OTHER THAN THE FIRST ONE BUT PERFORMED HIGH PRESSURE POBA IN THE LESION INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6766725 ↗
• MalfunctionJul 12, 2017Failure to Advance; Failure to Advance

  THIS FOLLOW UP MDR IS BEING SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. THE DELIVERY SYSTEM WAS INSERTED FROM THE RIGHT CFA TO THE LEFT IA CONTRALATERALLY, BUT IT COULD NOT ADVANCE TO THE CONTRALATERAL SIDE. THEN, ANOTHER DEVICE (ZIV5-18-125-8-40) WAS USED INSTEAD. THE REPLACEMENT COULD ADVANCE TO THE TARGET SITE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. ADDITIONAL INFORMATION PROVIDED THE WIRE GUIDE USED WAS CRUISE (SIZE UNKNOWN/ HYDROPHILIC) MANUFACTURED BY ASAHI INTECC. THE DELIVERY SYSTEM WAS FLUSHED THROUGH THE FLUSHING PORT BEFORE THE PROCEDURE AS PER PACKAGE INSERT. THE PATIENT ANATOMY WAS TORTUOUS. THE LOT# OF THE REPLACEMENT WHICH FINISHED THE PROCEDURE WAS C1213008, DIFFERENT FROM THE COMPLAINT DEVICE LOT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6705798 ↗