Zilver 518 G43791Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002437910), received between Oct 3, 2018 and May 7, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED THE STENT; HOWEVER, A PORTION OF IT WAS POSITIONED INCORRECTLY. THE DEVICE REPRESENTATIVE INDICATED THAT THERE WERE NO DEFECTS OR ISSUES WITH THE STENT ITSELF. THE PHYSICIAN PERFORMED A WIRE EXCHANGE PRIOR TO ADVANCING THE STENT; HOWEVER, THE GUIDEWIRE INADVERTENTLY TRACKED INTO AN UNINTENDED PATHWAY. AS A RESULT, WHEN THE STENT WAS DEPLOYED, IT WAS NOT POSITIONED AS EXPECTED. THE STENT ITSELF FUNCTIONED AS INTENDED. PATIENT WAS REPORTED FINE. CAN YOU CLARIFY WHAT EXACTLY IS MEANT IN THE DESCRIPTION OF EVENT: ¿¿A PORTION OF THE STENT WAS POSITIONED INCORRECTLY.¿ DOES THIS MEAN THAT A USE ERROR MAY HAVE OCCURRED AND IF SO, WHAT PART OF THE IFU WOULD THIS REFER TO? THE PHYSICIAN PERFORMED A WIRE EXCHANGE PRIOR TO ADVANCING THE STENT; HOWEVER, THE GUIDEWIRE INADVERTENTLY TRACKED INTO AN UNINTENDED PATHWAY. AS A RESULT, WHEN THE STENT WAS DEPLOYED, IT WAS NOT POSITIONED AS EXPECTED. THE STENT ITSELF FUNCTIONED AS INTENDED. WHAT WAS THE TARGET LOCATION FOR THE STENT? THE INTENDED TARGET LOCATION FOR THE STENT IS UNKNOWN, AS THE DEVICE WAS USED OFF-LABEL. WHAT DISEASE PATHOLOGY WAS BEING TREATED? UNKNOWN, AS THE DEVICE WAS USED OFF-LABEL. WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25115777 ↗
• MalfunctionMay 26, 2021Off-Label Use; Off-Label Use

  SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO THE INVESTIGATION BEING COMPLETED ON 04-JUN-2021. DEVICE WAS ALSO EVALUATED IN CIRL ON 26-MAY-2021, IMAGE REVIEW CARRIED OUT ON 02-JUN-2021. PER REP - (B)(6) 2021 - THE STENT STARTED DEPLOYING BEFORE THE RED SAFETY TAB HAD BEEN PULLED OUT. THEY ENDED UP DEPLOYING IT. THE LOCATION WAS A LITTLE BIT OFF BUT THE PROCEDURE WAS SUCCESSFUL. THE STENT WAS PLACED THROUGH A CATHETER. THE STENT STARTED DEPLOYING AS THEY WERE PULLING THE CATHETER BACK TO EXPOSE THE DELIVERY SYSTEM OF THE STENT. FROM IMAGES IT LOOKS LIKE THE DEPLOYED STENT IS FRACTURED AT THE PROXIMAL TIP THAT DEPLOYED EARLY. PATIENT OTCOME: 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 THA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11885306 ↗
• MalfunctionOct 3, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  WHILE TRYING TO INSERT THE ZILVER 518 THROUGH A .070 SOFIA CATHETER, THE DELIVERY SYSTEM WOULD NOT ADVANCE ANY FURTHER AND MET SIGNIFICANT RESISTANCE WHILE TRYING TO WITHDRAW. UPON REMOVING THE DELIVERY SYSTEM, THE STENT WAS PARTIALLY DEPLOYED AND UNSHEATHED WITHIN THE SYSTEM. HOWEVER, THE RED DEPLOYMENT LOCK HAD NOT BEEN REMOVED AT THE TIME THAT THIS OCCURRED. THE STENT WAS DEPLOYED IN THE STERILE FIELD AND THROWN AWAY DURING CLEAN UP. THE PROCEDURE WAS COMPLETED WITH A NEURON CATHETER AND A DIFFERENT STENT ZILVER 518.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7929860 ↗