NiCore Nitinol Guidewire 150NFA35Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741051463), received between May 14, 2021 and Sep 15, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT IN THE ONLINE SURVEY A PHYSICIAN STATED THAT "NO, THE GUIDEWIRE WAS NOT SUCCESSFUL IN PROVIDING PERCUTANEOUS ACCESS INTO THE URETER ¿ BECAUSE "THE GUIDE IS OUT" IN RELATION TO NITINOL GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17755727 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PHYSICIAN IN AN ONLINE SURVEY STATED THAT THE PATIENT EXPERIENCED PERFORATION PRIOR TO THE DEVICE PLACEMENT AND NO COMPLICATIONS WERE DIRECTLY ATTRIBUTABLE TO THE DEVICE IN RELATION TO THE NITINOL GUIDEWIRE. AS PER MAIL RECEIVED FROM IBC ON 23AUG2023, STATED THAT UPON RECEIPT OF THE FINAL DATASET FOR THE NICORE GUIDEWIRES THIS MORNING, THE ATTACHED FORM HAS BEEN UPDATED. ORIGINALLY READ ¿IN THE ONLINE SURVEY A PHYSICIAN STATED THAT THE PATIENT EXPERIENCED PERFORATION PRIOR TO THE DEVICE PLACEMENT AND NO COMPLICATIONS WERE DIRECTLY ATTRIBUTABLE TO THE DEVICE IN RELATION TO THE NITINOL GUIDEWIRE¿ HOWEVER, IT SHOULD READ ¿IN THE ONLINE SURVEY A PHYSICIAN STATED THAT THE PATIENT EXPERIENCED PERFORATION PRIOR TO THE DEVICE PLACEMENT AND PERFORATION AFTER PLACEMENT OF THE DEVICE. THE RESPONDENT INDICATED THEY BELIEVED THE COMPLICATION WAS DIRECTLY ATTRIBUTABLE TO THE DEVICE IN RELATION TO THE NITINOL GUIDEWIRE.¿ IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 17755258 ↗
• MalfunctionAug 30, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PHYSICIAN IN AN ONLINE SURVEY STATED THAT "NO, THE GUIDEWIRE WAS NOT SUCCESSFUL IN PROVIDING TRANSURETHRAL/PERCUTANEOUS ACCESS INTO THE BLADDER/URETER/RENAL PELVIS¿ BECAUSE "TIGHT URETER" IN RELATION TO THE NITINOL GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17652143 ↗
• MalfunctionAug 30, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT A PHYSICIAN IN AN ONLINE SURVEY STATED THAT "NO, THE GUIDEWIRE WAS NOT SUCCESSFUL IN PROVIDING TRANSURETHRAL/PERCUTANEOUS ACCESS INTO THE BLADDER/URETER/RENAL PELVIS¿ BECAUSE "TRACK COULD NOT BE ESTABLISHED DURING PUNCTURE AS GUIDE WIRE SLIPPED OUT" IN RELATION TO THE NITINOL GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17651832 ↗
• MalfunctionMay 14, 2021Flaked; Flaked

  IT WAS REPORTED THAT THE GUIDE WIRE WAS DAMAGED. A NEW GUIDEWIRE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826502 ↗