Zilver 518 G31352Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002313528), received between Feb 14, 2017 and Nov 25, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 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.

• MalfunctionNov 25, 2020Fracture; Device Damaged Prior to Use; Detachment of Device or Device Component; Fracture; Device Damaged Prior to Use; Detachment of Device or Device Component

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO A CORRECTIONS TO THE COMPLETED INVESTIGATION AND ANNEX CODES.

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

  MAUDE report 10904657 ↗
• MalfunctionNov 5, 2020Material Separation; Improper or Incorrect Procedure or Method; Material Deformation; Material Separation; Improper or Incorrect Procedure or Method; Material Deformation

  STENT WOULD NOT UNSHEATH AND DEPLOY. DEVICE WAS ABLE TO BE REMOVED WITH NO PROBLEMS AND HAS BEEN BAGGED IN ORDER TO BE SENT BACK. DEVICE EVALUATED 09-OCT-2020: "OUTER SHEATH AT WHITE CAP ON DISTAL END OF HANDLE - SEPARATED. INNER CATHETER AT APPROX. 2.5CM FROM WHITE CAP - KINKED. RED SAFETY LOCK - NOT RETURNED." 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. WAS THE DEVICE USED PERCUTANEOUSLY? YES. WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS SITE? CONTRALATERAL GROIN. DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? COOK ANSEL 6FRX55CM. WHAT WAS THE TARGET LOCATION

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

  MAUDE report 10792603 ↗
• MalfunctionFeb 14, 2017Premature Activation; Premature Activation

  IT WAS REPORTED WHILST ATTEMPTING TO PUT CATHETER OVER THE WIRE TIP OF CATHETER, STENT CAME OFF EXPOSING THE STENT. DID NOT ATTEMPT TO USE AFTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6328718 ↗