NiCore Nitinol Guidewire 150NFA38Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741051470), received between Aug 31, 2023 and Aug 31, 2023 — classified as 1 malfunction.

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

• MalfunctionAug 31, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED NO WHEN THEY ASKED THE GUIDEWIRE WAS SUCCESSFUL IN PROVIDING TRANSURETHRAL/PERCUTANEOUS ACCESS INTO THE BLADDER/URETER/RENAL PELVIS. PHYSICIAN STATED THE GUIDEWIRE WAS NOT SUCCESSFUL IN PROVIDING TRANSURETHRAL/PERCUTANEOUS ACCESS INTO THE BLADDER/URETER/RENAL PELVIS BECAUSE OOPS, THEY ACTUALLY WERE IN RELATION TO 150NFA38 NICORE¿ NITINOL/NITINOL GUIDEWIRE, .038 IN., 3CM, 150CM, STANDARD, ANGLED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 23AUG2023, IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED THAT NO, THE GUIDEWIRE WAS NOT SUCCESSFUL IN PROVIDING TRANSURETHRAL ACCESS INTO THE URETER BECAUSE OOPS, THEY ACTUALLY WERE IN RELATION TO 150NFA38 NICORE¿ NITINOL/NITINOL GUIDEWIRE, .038 IN., 3CM, 150CM, STANDARD, ANGLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17661430 ↗