GLIDEWIRE UWR1035Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04987350754394), received between May 12, 2023 and Oct 12, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 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.

• MalfunctionOct 12, 2023Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE DOCTOR (GENERAL SURGEON) WAS DOING A PORTACATH PLACEMENT AND UPON RETRACTING THE GLIDEWIRE HE NOTICED THAT PART OF THE POLYMER COATING WAS MISSING. THEY WERE ABLE TO FIND THE SHAVED OFF WIRE AND THERE WAS NO HARM TO PATIENT. THE PATIENT WAS STABLE. THERE WAS NO BLOOD LOSS, AND NO PATIENT INJURY AND/OR MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 21SEPT2023: NO FRAGMENT WAS LEFT IN PATIENT BODY. PRODUCT WAS USED WITH A LINE INSERTION KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17928209 ↗
• InjuryMay 12, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE OLYMPUS GUIDEWIRE BROKE OFF INTO THE PATIENT. THE DOCTOR WAS GOING TO CONTACT (B)(6) FOR HELP TO REMOVE THE WIRE AS IT WAS STILL IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16917186 ↗
• InjuryMay 12, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE OLYMPUS GUIDEWIRE BROKE OFF INTO THE PATIENT. THE DOCTOR WAS GOING TO CONTACT HARRISBURG FOR HELP TO REMOVE THE WIRE AS IT WAS STILL IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16917160 ↗