NA 5100010060Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540074515), received between Aug 29, 2019 and Apr 28, 2021 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2021Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED DURING TESTING PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11738760 ↗
• InjuryAug 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THREE METAL OBJECTS WERE OBSERVED IN THE PATIENT'S SKULL DURING A POST-OP SCAN FOLLOWING A PROCEDURE IN WHICH THE DEVICE HAD BEEN IN USE. THE USER FACILITY REPORTED A REVISION PROCEDURE WAS PERFORMED AND 2 OF THE 3 METAL OBJECTS WERE SUCCESSFULLY RETRIEVED. ONE OBJECT REMAINS IN PLACE. THERE WAS NO ALLEGATION OF DEVICE FAILURE DURING THE INITIAL PROCEDURE. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8946471 ↗