Zilver 518 G43778Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10827002437781), received between Mar 14, 2018 and Mar 31, 2025 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2025Device Damaged Prior to Use; Device Damaged Prior to Use

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 20-MAY-25.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729551 ↗
• MalfunctionMar 26, 2025Device Damaged Prior to Use; Manufacturing, Packaging or Shipping Problem; Device Damaged Prior to Use; Manufacturing, Packaging or Shipping Problem

  UPON WITHDRAWAL OF STENT DELIVERY SYSTEM FROM THE PACKAGING AND FLUSHING PROCESS, IT WAS NOTICED THAT THERE WAS A GAP AT THE DISTAL END OF THE SYSTEM BETWEEN THE OUTER SHEATH AND THE WHITE INNER CATHETER TIP. DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THE IS OCCURRENCE. ((B)(6)). THIS ADDITIONAL COMPLAINT WAS OPENED TO CAPTURE THE STENT STRUT DAMAGE SEEN IN THE DEVICE EVALUATION. ENGINEERING INPUT CONFIRMED THIS DAMAGE WAS UNRELATED TO THE ORIGINAL COMPLAINT REPORTED. NO PATIENT INFORMATION PROVIDED AS DEVICE WAS NOT USED ON THE PATIENT. PRIOR TO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21702065 ↗
• MalfunctionMay 3, 2023Off-Label Use; Off-Label Use

  WHEN WENT TO DEPLOY THE STENT ELONGATED,THE PHYSICIAN PUT ANOTHER STENT ON THE INSIDE TO COVER UP THE STRETCHED-OUT PART. THIS INFORMATION WAS PROVIDED VIA PHONE CALL (B)(6) 2023. 1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. 2. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO. 3. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. 4. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. 5. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. 6. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? N/A. THE FOLLOWING INFORMATION HAS BEEN RECEIVED VIA PHONE CALL ON (B)(6) 2023. (B)(6) 2023. 3.32 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO. 3.33 AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? STENT PLACEMENT. 3.34 DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? 5FR X 45CM. 3.35 WHAT WAS THE TARGET LOCATION FOR THE STENT? SFA (SUPERFICIAL FEMORAL ARTERY). 3.36 WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? YES. 3.37 WAS THE DEVICE USED PERCUTANEOUSLY? YES. 3.38 WAS TH

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 16859719 ↗
• MalfunctionApr 3, 2023Off-Label Use; Off-Label Use

  SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO THE COMPLETION OF INVESTIGATION ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16662147 ↗
• MalfunctionMar 3, 2023Off-Label Use; Off-Label Use

  SUPPLEMENTAL FOLLOW-UP MDR REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 19-MAY-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16477206 ↗
• InjuryOct 5, 2022Off-Label Use; Off-Label Use

  AS REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION "ONCE THE STENT WAS ADVANCED TO THE LESION, THE PHYSICIAN REALIZED THAT IT APPEARED AS THOUGH THE SHEATH WAS DETACHED FROM THE HANDLE (THE BLUE PORTION OF THE SHEATH). THEREFORE, THE PHYSICIAN WAS WORRIED ABOUT PLACING THE STENT. THE PHYSICIAN DECIDED HE WAS GOING TO REMOVE THE STENT AND THE SHEATH - DUE TO DETACHMENT. HOWEVER, IN DOING SO, THE PHYSICIAN PULLED THE BLUE PORTION OF THE SHEATH; THEREBY DEPLOYING THE STENT. THE STENT DEPLOYED AND THE PHYSICIAN WAS RATHER PLEASED WITH PLACEMENT." THE USER USED THIS DEVICE FOR THE TREATMENT OF A LESION ON THE SFA. THIS IS CONSIDERED OFF LABEL USE. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. IF YES, PLEASE DESCRIBE. N/A. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. IF YES, PLEASE DESCRIBE. N/A. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. N/A. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15543864 ↗
• MalfunctionSep 21, 2022Off-Label Use; Off-Label Use

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 20-JAN-23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460597 ↗
• MalfunctionSep 9, 2022Off-Label Use; Off-Label Use

  PER REP - (B)(6) 2022 - THE DELIVERY SHEATH BECAME UNATTACHED FROM THE HUB. THEY REMOVED THE STENT AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH A MEDTRONIC STENT. 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 DUE TO THIS OCCURRENCE? 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? N/A, YES, NO. NO. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? UNPACKING OR PREPARATION OF THE DEVICE, INSERTION, STENT PLACEMENT, REMOVING THE INTRODUCER. PREPARING FOR STENT DEPLOYMENT. DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? COOK 5 FR 45 CM. WHAT WAS THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15389561 ↗
• MalfunctionJun 2, 2022Off-Label Use; Off-Label Use

  REPORTED BY THE DM ON BEHALF OF THE CUSTOMER VIA EMAIL - DEFECTIVE DEPLOYMENT. PATIENT WAS UNHARMED. NO FOREIGN BODY LEFT INSIDE PATIENT. THE FOLLOWING HAS BEEN REQUESTED- (B)(6) 2022. THE FOLLOWING HAS BEEN ANSWERED- (B)(6) 2022. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO IF YES, PLEASE DESCRIBE. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO 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. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE THIS OCCURRENCE? NO. THE FOLLOWING HAS BEEN REQUESTED- (B)(6)2022 ZIV5/ZIV6/ZFV6 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? YES. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? UNPACKING OR PREPARATION OF THE DEVICE, INSERTION, STENT PLACEMENT, REMOVING THE INTRODUCER. INSERTION. DETAILS OF ACCESS SHEATH USED (NAME, FR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14574582 ↗
• MalfunctionJun 1, 2022Off-Label Use; Off-Label Use

  HANDLE BROKE WHEN DEPLOYING STENT. NO HARM TO THE PATIENT. WAS ABLE TO DEPLOY THE STENT SUCCESSFULLY. WOULD LIKE TO RETURN HANDLE TO VENDOR FOR AN EVALUATION. AS PER CLINICAL INPUT ON (B)(6) 2022: THE BELOW COMPLAINT ANSWERS SHOW THAT THE ZIV5 DEVICE WAS USED FOR NEURO STENTING. YES NEURO REFERS TO NEUROLOGICAL SO THIS IS OFF-LABEL USE. 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. WHAT WAS THE DATE OF THE EVENT? ON (B)(6) 2021. WILL YOUR FACILITY BE REPORTING THIS EVENT TO THE FDA? NO. WOULD YOU LIKE A CREDIT OR NO CHARGE REPLACEMENT DEVICE TO BE ISSUED? NO. IF SO, PLEASE CHOOSE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14566161 ↗
• MalfunctionNov 22, 2021Off-Label Use; Off-Label Use

  COMPLETE MDR BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 07-APR-2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12851772 ↗
• MalfunctionNov 18, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AN (B)(6) FEMALE PATIENT UNDERWENT A LEFT LEG INTERVENTION PROCEDURE IN WHICH THE ZILVER 518 VASCULAR SELF-EXPANDING STENT, G43778, WAS USED. WHEN TRYING TO DEPLOY THE STENT THE FLEXOR DELIVERY CATHETER CAME APART AT THE HUB. THE DEVICE WAS REMOVED FROM THE PATIENT AND ANOTHER OF THE SAME DEVICE & LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE. 1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO IF YES, PLEASE DESCRIBE. 2. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO 3. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO IF YES, PLEASE DESCRIBE. 4. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. 5. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO 6. 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 3.35 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO 3.36 AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? STENT PLACEMENT 3.37 DETAILS OF ACCESS SHEAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12834581 ↗
• MalfunctionDec 22, 2020Premature Activation; Improper or Incorrect Procedure or Method; Premature Activation; Improper or Incorrect Procedure or Method

  PLAN: PLACING ZIV5-18-125-7-80 IN THE RIGHT EIA BY LEFT BRACHIAL APPROACH AND PLACING ZIV6-35-80-10-80 IN THE RIGHT CIA BY RIGHT FEMORAL APPROACH. AFTER REMOVING THE ZIV5-18-125-7-80 FROM THE PACKAGING, THE PHYSICIAN ATTEMPTED TO FLUSH THE DELIVERY SYSTEM FROM THE SIDE-ARM FLUSHING PORT WITH THE 1MM SYRINGE WHICH WAS INCLUDED IN THE PACKAGING. HOWEVER, BECAUSE SALINE DID NOT EXIT THE DISTAL TIP BUT RETURNED TO THE SYRINGE, THE PHYSICIAN FLUSHED ONLY THROUGH THE WIRE LUMEN AND CONTINUED TO USE THE DEVICE ((B)(4)). THE PHYSICIAN HAD A DIFFICULTY IN PULLING THE HANDLE DUE TO STRONG RESISTANCE WHEN ATTEMPTING TO DEPLOY THE STENT. HE APPLIED SOME MORE FORCE, THEN THE STENT POPPED OUT A LITTLE, BUT AFTER THAT, IT COULD BE DEPLOYED SMOOTHLY AND PLACED IN THE RIGHT EIA SUCCESSFULLY ((B)(4)). AFTER THAT, THE PHYSICIAN ATTEMPTED TO PLACE THE ZIV6-35-80-10-80, BUT HE ENCOUNTERED SLIGHT RESISTANCE DURING DEPLOYMENT OF THE STENT. THE APPROXIMATELY 4CM OF THE STENT WAS DEPLOYED WITH ELONGATION, WHICH MIGHT HAVE BEEN EFFECTED BY THE DEPLOYMENT DIFFICULTY WHICH THE PHYSICIAN FELT DURING DEPLOYMENT. HOWEVER, AFTER DEPLOYING THE FIRST 4CM (ELONGATED PART), THE STENT COULD BE DEPLOYED NORMALLY AND TH

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11055746 ↗
• MalfunctionMar 14, 2018Difficult to Remove; Difficult to Remove

  INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿DEPLOYMENT DIFFICULTY RESULTING IN A PARTIAL STENT DEPLOYMENT'. LAB EVALUATION PERFORMED 15-FEB-2018. STENT RETURNED PARTIALLY DEPLOYED. WITH MINIMAL DIFFICULTY, THEY WERE ABLE TO GET THE DEVICE OVER THE WIRE GUIDE; HOWEVER, DUE TO THE PATIENT ANATOMY AND WHAT THE DM BELIEVES WAS THE CONDITION OF THE WIRE (THE WIRE SEEMED TO HAVE KINKS AND THEY HAD PREVIOUSLY CUT THE END AT THE WIRE), THEY COULD NOT CROSS OVER TO THE OTHER SIDE. THEY REMOVED THE DEVICE FROM THE PATIENT AND TRIED TO PULL STENT OFF OF THE WIRE BUT GOT STUCK ON THE WIRE. THEY HAD TO CUT PART OF THE WIRE OFF AND SOME OF THE WIRE REMAINS IN THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7337717 ↗