GLIDEWIRE GS3805Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04987350773777), received between Oct 13, 2016 and Oct 13, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 13, 2016Break; Break

  THE USER FACILITY REPORTED THAT THE COATING OF THE DEVICE USED HAD SHEARED OFF THE WIRE DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE WIRE WAS PLACED THROUGH A COOK DAV CATHETER; THE CATHETER WAS PLACED THROUGH AN ARROW SHEATH WITH A SAFETY WIRE OF AN UNKNOWN MANUFACTURER; WHILE TRYING TO REMOVE THE WIRE FROM WITHIN THE PATIENT THROUGH THE DAV CATHETER, THE COATING SHEARED OFF THE WIRE; THE SHEARED COATING WENT INTO THE PATIENT'S BLADDER; AND THE WIRE WAS RETRIEVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6026247 ↗