Zilver 518 G43787Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002437873), received between Sep 15, 2021 and Nov 25, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 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 16, 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.

• MalfunctionNov 25, 2025Off-Label Use; Off-Label Use

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 15-JAN-26. THE FOLLOWING INFORMATION HAS BEEN RECEIVED VIA EMAIL ON 02DEC2025. 1. IS AN ACKNOWLEDGMENT LETTER (FORMAL NOTIFICATION OF THE COMPLAINT BEING RECEIVED) REQUIRED? NO. 2. IS ANY ACCOUNT ACTION NEEDED (CREDIT, NO CHARGE REPLACEMENT, NO ACTION, INVESTIGATION RESULTS, ETC.) NO. 3. DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? NOT SURE. 4. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHILIC)? BOSTON V18. 5. WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? NO. 6. WAS THE APPROACH IPSILATERAL OR CONTRALATERAL? N/A, ISPILATERAL, CONTRALATERAL (IF CONTRALATERAL, WAS THE BIFURCATION ANGLE STEEP? N/A, YES, NO) CONTRA. UP INTO SINUS 7. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM PRIOR TO RETURN (E.G., KINK)? N/A, YES, NO (IF YES, PLEASE SPECIFY WHAT ADDITIONAL DEFECT(S) WERE OBSERVED AND WHERE ON THE DEVICE THIS WAS OBSERVED) NO. 8. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? YES. 9. DID THE TIP OF THE DELIVERY SYSTEM CROSS THE TARGET LOCATION? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643460 ↗
• MalfunctionNov 17, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS WAS A CASE OF CONTRALATERAL APPROACH TO AN EXTERNAL ILIAC ARTERY. ZIV5-18-125-9-60 WAS ATTEMPTED TO BE DEPLOYED, BUT THE OUTER SHEATH CAME OFF THE HUB SO IT WAS TAKEN OUT OF THE PATIENT. (B)(4). THE USER CHANGED THE WIRE GUIDE FROM 0.014 INCH TO 0.018 INCH AND TRIED DEPLOYING AGAIN WITH ZIV5-18-125-9-80, BUT THE OUTER SHEATH CAME OFF AGAIN. (B)(4). THE PROCEDURE WAS COMPLETED BY FORCIBLY PULLING THE OUTER SHEATH OF ZIV5-18-125-9-80 AND DEPLOYING THE STENT - OFF LABEL USE. (B)(4) <PHYSICIAN'S COMMENT> THE PATIENT'S ANATOMY WAS HIGHLY TORTUOUS, WHICH MAY HAVE BEEN A FACTOR. 3-1 WAS THE DEVICE USED PERCUTANEOUSLY? YES 3-2 WHICH ARTERY WAS THE STENT TO BE PLACED IN? EIA (EXTERNAL ILIAC ARTERY) 3-3 WAS THE APPROACH IPSILATERAL OR CONTRALATERAL? (CONTRALATERAL) 3-4 IF CONTRALATERAL, WAS THE BIFURCATION ANGLE TIGHT? YES 3-5 WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS SITE? FA (FEMORAL ARTERY) 3-6 DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? MEDIKIT/PARENT PLUS 60 6FR 75CM 3-7 WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORT BEFORE THE PROCEDURE, AS PER IFU? YES 3-8 DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYRDOPHYLLIC)? NIPRO/CHEVALIER FLOOPY 0.014INCH HYDROPHI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18158166 ↗
• MalfunctionMar 21, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ADDITIONAL COMPLAINT CREATED BASED ON INSTRUCTION FROM CIRL "THE USER SHOULD HAVE PLACED THE SECOND STENT PROXIMALLY TO THE PREVIOUSLY PLACED STENT." "AFTER FORMULA STENT WAS PLACED IN THE INTERVENTION LEFT COMMON ILIAC ARTERY THEY ATTEMPTED TO PLACE 9X60 SES STENT AND WOULD NOT CROSS CAUSING FORMULA STENT TO "CRINKLE" AT THE PROXIMAL END. THEY REMOVED THE STENT AND INSERTED THE SHORTER 9X40 STENT WHICH CROSSED, FOLLOWED UP BY 9X80 STENT." THIS FILE WILL CAPTURE THE USER ERROR OF NOT PLACING THE SECOND STENT PROXIMALLY TO THE FIRST ADDITIONAL INFO RECEIVED 22-SEP-2021: 1. WHAT WAS THE SIZE (DIAMETER) OF THE WIRE GUIDE USED IN THE PROCEDURE? -014. 2. CAN YOU PLEASE CLARIFY WHICH PART OF THE DEVICE WAS OBSERVED AS 'CRINKLED'. WAS IT THE BARE METAL STENT ( THE DEVICE WHICH IS IMPLANTED INTO THE PATIENT), OR THE PROXIMAL END OF THE DELIVERY SYSTEM ( THE DEVICE WHICH IS USED TO DELIVER THE METAL STENT TO THE TARGET LOCATION). -THE PREVIOUSLY PLACED STENT WAS OBSERVED BEING CRINKLED DUE TO THE ADVANCEMENT OF THE SECOND STENT. WHEN MD NOTICED IT CRINKLING HE DID NOT FORCE IT AND REMOVED THE STENT UNDEPLOYED. HE THEN OPTED TO PLACE A LONGER STENT WHICH PASSED THRU WITH NO PROBLEM. 3. AT WH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840882 ↗
• MalfunctionSep 15, 2021Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO CONFIRMATION ON 18-OCT-21 THAT USER ERROR OCCURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12475217 ↗