Zilver 518 G43782Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002437828), received between Aug 29, 2018 and May 11, 2023 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2023Off-Label Use; Off-Label Use

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF A LAB EVALUATION ON 25-MAY-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16910768 ↗
• MalfunctionNov 18, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION "THE FLEXOR PART DETACHED FROM THE HANDLE THEREFORE THE STENT WAS UNDEPLOYABLE." DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO IF YES, PLEASE DESCRIBE. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO IF YES, PLEASE DESCRIBE. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES 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. ZIV5/ZIV6/ZFV6 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? STENT PLACEMENT DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? COOK 545 WHAT WAS THE TARGET LOCATION FOR THE STENT? SFA WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? N/A WAS THE DEVICE USED PERCUTANEOUSLY? NO WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORT B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12834736 ↗
• MalfunctionJun 25, 2021Off-Label Use; Off-Label Use

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A STANDARD ANGIO PROCEDURE IN WHICH THE ZILVER 518 VASCULAR SELF-EXPANDING STENT, G43782, WAS USED. THE FLEXOR PART DISATTACHED FROM THE HANDLE THEREFORE THE STENT WAS NOT DEPLOYED. AS THE OTHER G43782 THE CUSTOMER HAD WAS THE SAME LOT NUMBER AND IT WAS NOT TRUSTED BY THE CUSTOMER THEY USED A DIFFERENT SIZE OF A ZILVER 518 TO COMPLETE THE PROCEDURE WITH NO FURTHER COMPLICATIONS. PATIENT OUTCOME: DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO IF YES, PLEASE DESCRIBE. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO IF YES, PLEASE DESCRIBE. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12065400 ↗
• MalfunctionJan 3, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS REPORTED TO CUSTOMER RELATIONS, "VERY DIFFICULT TO MOVE THE STENT THRU THE SHEATH FROM THE BEGINNING. THE PHYSICIAN COMMENTED TO THE DISTRICT MANAGER IT FELT LIKE HE WAS PLACING A 6FR STENT THRU A 5FR SHEATH. ALSO NOTE, OTHER DEVICES WERE PLACED THRU THE SHEATH SUCCESSFULLY PRIOR TO THE STENT. THE PROCEDURE WAS COMPLETED WITH THE COMPLAINT DEVICE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8212009 ↗
• MalfunctionAug 29, 2018Break; Break

  EVT OF THE BOTH SIDES OF CIA BY USING ¿SHOT-GUN STENTING¿ TECHNIQUE WAS PERFORMED. IN THE RIGHT SIDE OF AORTIC BIFURCATION(BEGINNING PART OF RIGHT CIA) WAS A SEVERE TORTUOSITY, BUT A WIRE GUIDE(COMMAND 0.014 INCH / ABOTT) CROSSED THE TORTUOSITY WITHOUT PROBLEMS. LEFT BRACHIAL ARTERY WAS PUNCTURED AND A 10*60 ZIV WAS ADVANCED TO LEFT CIA. ALTHOUGH DIFFICULTY WAS ENCOUNTERED DURING DELIVERY, IT COULD BE MADE TO REACH THE LESION SUCCESSFULLY. RIGHT FEMORAL ARTERY WAS PUNCTURED AND A GUIDING SHEATH(DETAIL: UNKNOWN) WAS INSERTED. WHILE INSERTION OF THE SHEATH, SLIGHT RESISTANCE WAS ENCOUNTERED. THEN, THE COMPLAINT ZIV5-18-125-8-60 WAS ADVANCED TO THE LESION IN RIGHT CIA THROUGH THE SHEATH. THE STENT OF 10*60 ZIV ADVANCED FROM LEFT BRACHIAL ARTERY COULD BE DEPLOYED IN THE LEFT CIA WITHOUT PROBLEMS. HOWEVER, THE OUTER SHEATH OF THE COMPLAINT DEVICE(WHICH WAS ADVANCED FROM RIGHT FEMORAL ARTERY) CAME OFF THE HANDLE SOON AFTER THE PHYSICIAN STARTED TO PULL BACK THE HANDLE TO DEPLOY THE STENT. ANY PARTS OF THE STENT HAD NOT BEEN DEPLOYED IN THE ARTERY YET WHEN THE DETACHMENT OF THE OUTER SHEATH OCCURRED. SO, THE PHYSICIAN MANAGED TO RETRIEVE THE SYSTEM OUT OF THE BODY WHILE GRASPING THE INNER

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7826980 ↗