NiCore Nitinol Guidewire 150NSA35Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741051500), received between Apr 17, 2020 and Sep 17, 2025 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Flaked” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Flaked; Flaked

  IT WAS REPORTED THAT DURING USE, THE GUIDEWIRE COATING/SHEATHING OF THE WIRE CAME LOOSE AND REMAINED STUCK IN THE VESSEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073170 ↗
• MalfunctionAug 20, 2025Flaked; Material Split, Cut or Torn; Flaked; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE GUIDEWIRE WAS SOLD BY THE COMPANY TO (B)(6) HOSPITAL IN (B)(6) ON (B)(6) 2025. ON (B)(6) 2025, WHEN (B)(6) HOSPITAL WAS USING THE GUIDE WIRE, THEY OPENED THE PACKAGING, TOOK OUT THE GUIDE WIRE, AND FOUND THAT THE TIP OF THE GUIDE WIRE WAS SPLIT. THAT DAY, THE HOSPITAL CONTACTED THE COMPANY AND ALSO PROVIDED DETAILED INFORMATION TO THE COMPANY ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22853454 ↗
• MalfunctionMar 3, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING BILATERAL URETERAL LITHOTRIPSY, THE SHEATH OF THE GUIDEWIRE OF THE PRODUCT WAS BROKEN DURING THE LEFT URETERAL PUSHING, BUT IT WAS STILL USED, AND THE DOCTOR CONTINUED TO COMPLETE THE OPERATION, BUT THE SHEATH BREAKS OFF IN THE RIGHT URETERAL GUIDEWIRE PUSHING, AND THE TARGET POSITION CANNOT BE PUSHED DURING THE STENT TUBE PUSHING, AND A NEW GUIDEWIRE OF THE SAME TYPE WAS OPENED TO COMPLETE THE OPERATION. PATIENT HAD PROLONGED SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21503972 ↗
• MalfunctionOct 15, 2024Flaked; Flaked

  IT WAS REPORTED THAT THE GUIDEWIRE HAD BEEN USED, THE GUIDEWIRE APPEARS WRINKLED AND WARPED, AND THE URETEROSCOPY WAS SOFT, AFTER THE LITHOTRIPSY WAS COMPLETED, THE GUIDEWIRE WAS READY TO BE INSERTED, THE STENT WAS PLACED, AND THE GUIDEWIRE WAS OBVIOUSLY WRINKLED AND PEELED UNDER THE MICROSCOPE, AND THE HARD AND SOFT SHEATH ARE USED DURING THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20450970 ↗
• MalfunctionAug 24, 2023Flaked; Flaked

  IT WAS REPORTED THAT UPON UNPACKING, IT WAS FOUND THAT THE COATING ON THE NITINOL GUIDEWIRE WIRE FELL OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17618302 ↗
• MalfunctionJul 5, 2023Flaked; Flaked

  IT WAS REPORTED THAT PRIOR TO OPERATION, IT WAS FOUND THAT THE COATING OF THE GUIDE WIRE FLAKED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259451 ↗
• MalfunctionDec 29, 2022Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT GREAT RESISTANCE WAS FELT WHEN DEVICES WERE INSERTED OVER THE GUIDEWIRE WITH UNSMOOTH COATING ON THE SURFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16067330 ↗
• MalfunctionDec 6, 2022Flaked; Material Fragmentation; Flaked; Material Fragmentation

  IT WAS REPORTED THAT THE PERCUTANEOUS NEPHROLITHOTOMY WAS PERFORMED FOR THE PATIENT ON (B)(6) AT 8:30 AM. PRIOR TO USE, THE OUTER PACKAGE WAS INSPECTED FOR INTEGRITY AND NO ABNORMALITIES WERE FOUND. UPON OPENING THE OUTER PACKAGE, THE INNER STEEL WIRE AT THE PROXIMAL END OF THE GUIDE WIRE WAS FOUND EXPOSED EXTERNALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15923858 ↗
• MalfunctionDec 5, 2022Flaked; Material Fragmentation; Flaked; Material Fragmentation

  IT WAS REPORTED THAT THE PERCUTANEOUS NEPHROLITHOTOMY WAS PERFORMED FOR THE PATIENT ON (B)(6) AT 13:00PM. PRIOR TO USE, THE OUTER PACKAGE WAS INSPECTED FOR INTEGRITY AND NO ABNORMALITIES WERE FOUND. UPON OPENING THE OUTER PACKAGE, THE INNER STEEL WIRE AT THE PROXIMAL END OF THE GUIDE WIRE WAS FOUND EXPOSED EXTERNALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15915873 ↗
• MalfunctionSep 2, 2022Material Fragmentation; Material Twisted/Bent; Material Fragmentation; Material Twisted/Bent

  IT WAS REPORTED THAT THE HEAD OF THE GUIDE WIRE WAS DAMAGED AND COULD NOT BE USED NORMALLY AFTER THE PRODUCT WAS UNPACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15347152 ↗
• MalfunctionSep 2, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE OUTER PACKAGE OF THE NITINOL GUIDEWIRE PRODUCT WAS CHECKED FOR INTEGRITY PRIOR TO USE AND NO ABNORMALITIES WERE FOUND. AFTER THE OUTER PACKAGE WAS OPENED, THE STEEL WIRE OF THE GUIDE WIRE AT THE TIP WAS EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12417691 ↗
• MalfunctionSep 2, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT INTERNAL WIRE AT THE TIP OF THE GUIDE WIRE WAS EXPOSED AFTER OPENING THE OUTER PACKAGING. NURSE STATED THAT THE OUTER PACKAGE OF THE PRODUCT WAS CHECKED PRIOR TO USE AND NO ABNORMALITIES WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12413862 ↗
• MalfunctionAug 6, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT AFTER THE GUIDEWIRE WAS OPENED, THE PRIMARY PACKAGE WAS FOUND DAMAGED IN A NON-STERILE STATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12287503 ↗
• MalfunctionMay 31, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE PERCUTANEOUS NEPHROLITHOTOMY WAS PERFORMED FOR THE PATIENT ON (B)(6) 2021. IT WAS STATED THAT THE INTERNAL STEEL WIRE OF THE GUIDE WIRE AT THE PROXIMAL END WAS FOUND EXPOSED EXTERNALLY WHEN THE OUTER PACKAGE WAS OPENED. THE OUTER PACKAGE OF THE PRODUCT WAS CHECKED FOR INTEGRITY PRIOR TO USE AND NO ABNORMALITIES WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11910356 ↗
• MalfunctionMay 31, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE PERCUTANEOUS NEPHROLITHOTOMY WAS PERFORMED FOR THE PATIENT ON (B)(6) 2021. IT WAS STATED THAT THE INTERNAL STEEL WIRE OF THE GUIDE WIRE AT THE PROXIMAL END WAS FOUND EXPOSED EXTERNALLY WHEN THE OUTER PACKAGE WAS OPENED. THE OUTER PACKAGE OF THE PRODUCT WAS CHECKED FOR INTEGRITY PRIOR TO USE AND NO ABNORMALITIES WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11910354 ↗
• InjuryApr 17, 2020Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRES CONTAINED A STEEL WIRED CORE, AND AS A RESULT THE TIPS WERE STIFF. ALLEGEDLY, THIS CAUSED MULTIPLE FASCIA OF THE KIDNEY, RESULTING IN FALSE ACCESS. THE COMPLAINANT NOTED THAT THE PREVIOUSLY USED GUIDEWIRES DID NOT HAVE THE STEEL WIRED CORE AT THE FLEXIBLE CROOKED TIP. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 14 APRIL 2020 FROM IBC REPRESENTATIVE, THE USER IMMEDIATELY WITHDREW THE GUIDE WIRE AFTER THE FALSE ACCESS WAS FOUND. THE REMOVAL PREVENTED FURTHER DAMAGE TO THE PATIENT. THERE WAS NO OTHER SPECIAL TREATMENT.

  Patient problems: Injury; Tissue Damage

  MAUDE report 9973406 ↗