Zilver 518 G36048Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002360485), received between Sep 21, 2017 and Aug 19, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (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 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.

• MalfunctionAug 19, 2022Off-Label Use; Off-Label Use

  WHEN PINNED AND PULLED, THE STENT FLOWERED OUT, BUT THE LAST 1 CM OF THE STENT WOULD NOT EXIT OUT. THE DEVICE WAS COMPLETELY PULLED BACK TO THE HUB. THE STENT SHOULD HAVE COMPLETELY DEPLOYED AT THIS POINT. THE USER PULLED THE WHOLE DEPLOYMENT SYSTEM BACK TO DEPLOY STENT IN TARGET SITE. THIS OCCURRED WITH EVERY STENT USED IN THIS CASE: (B)(4) ¿ G43773, LOT NUMBER C1753166, (B)(4) ¿ G43773, LOT NUMBER C1794186, (B)(4) ¿ G43773, LOT NUMBER C1633402, (B)(4) ¿ G36048, LOT NUMBER C1778086, (B)(4) ¿ G36048, LOT NUMBER C1810418. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO. 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. 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? NA. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? STENT PLACEMENT DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? 5 FR TERUMO SLENDER SHEATH DID THE PATIENT REQUIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15257670 ↗
• MalfunctionAug 19, 2022Off-Label Use; Off-Label Use

  WHEN PINNED AND PULLED, THE STENT FLOWERED OUT, BUT THE LAST 1 CM OF THE STENT WOULD NOT EXIT OUT. THE DEVICE WAS COMPLETELY PULLED BACK TO THE HUB. THE STENT SHOULD HAVE COMPLETELY DEPLOYED AT THIS POINT. THE USER PULLED THE WHOLE DEPLOYMENT SYSTEM BACK TO DEPLOY STENT IN TARGET SITE. THIS OCCURRED WITH EVERY STENT USED IN THIS CASE: (B)(4)¿ G43773, LOT NUMBER C1753166. (B)(4)¿ G43773, LOT NUMBER C1794186. (B)(4)¿ G43773, LOT NUMBER C1633402. (B)(4)¿ G36048, LOT NUMBER C1778086. (B)(4)¿ G36048, LOT NUMBER C1810418. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO. 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. 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? NA. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? STENT PLACEMENT. DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? 5 FR TERUMO SLENDER SHEATH. DID THE PATIENT REQUIRE A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15257627 ↗
• MalfunctionJul 1, 2022Off-Label Use; Off-Label Use

  PER REP - (B)(6) 2022 - THE STENT WOULD NOT CROSS THE LESION. PER REP - (B)(6) 2022 - HOW WAS THE PROCEDURE COMPLETED? BY UTILIZING A COMPETITOR 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. INSERTION. DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? WHAT WAS THE TARGET LOCATION FOR THE STENT? CAROTID. WAS THE PRODU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14883841 ↗
• MalfunctionSep 21, 2017Stretched; Stretched

  THE PHYSICIAN DEPLOYED THE STENT AND AFTER DEPLOYMENT, THEY WENT TO PLACE THE BALLOON; HOWEVER, THEY REALIZED THE STENT PLACED WAS THE INCORRECT SIZE FROM WHAT THE PACKAGING SAID. SHOULD HAVE BEEN A 5.0-80 BUT WAS A 5.0-100. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH THE STENT SUCCESSFULLY. CONSERVATIVE INTERPRETATION OF 'STENT ELONGATION' UNTIL CLARIFICATION IS RECEIVED; INVESTIGATION IS STILL IN PROGRESS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6882059 ↗