NiCore Nitinol Guidewire 150NFS35Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00801741051487), received between Sep 26, 2017 and Apr 29, 2025 — classified as 1 injury, 29 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Flaked; Flaked

  IT WAS REPORTED THAT THE PATIENT UNDERWENT URETEROSCOPY LITHOTRIPSY FOR KIDNEY STONES. THE ULTRA-SMOOTH GUIDEWIRE 150NFS35 WAS USED FOR THE SURGERY. IT WAS SMOOTH WHEN IT WAS FIRST INSERTED AND USED NORMALLY. AFTER A PERIOD OF PLACEMENT, THE GUIDEWIRE WAS INSERTED AGAIN. THE GUIDEWIRE WAS RELATIVELY DRY. THE CLINICAL GUIDEWIRE WAS ACTIVATED AGAIN WITH SALINE INJECTION, BUT THE GUIDEWIRE STILL FELT UNLUBRICATED, AND THE GUIDEWIRE COATING FELL OFF. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH THE USE OF THE GUIDEWIRE, BUT THE GUIDEWIRE WAS DIFFICULT TO INSERT, AND THE SURGERY TIME WAS PROLONGED DUE TO ITS NON-SMOOTHNESS. THE UNIT HAS BEEN USING 150NFS35 FOR A LONG TIME. ACCORDING TO CLINICAL FEEDBACK, THE SECOND INSERTION OF THE GUIDEWIRE WAS OCCASIONALLY NOT SMOOTH, WHICH HAS SOME IMPACT ON CLINICAL SURGERY AND PROLONGED SURGERY TIME. ADHERENCE TO THE GUIDEWIRE RESULTED IN SUCCESSFUL COMPLETION OF THE PROCEDURE, BUT DIFFICULTY IN PLACEMENT AND PROLONGATION OF THE PROCEDURE DUE TO THE NON-SMOOTHNESS OF THE GUIDEWIRE.

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

  MAUDE report 21927117 ↗
• MalfunctionApr 29, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT UNDERWENT URETEROSCOPY LITHOTRIPSY FOR KIDNEY STONES. THE ULTRA-SMOOTH GUIDEWIRE 150NFS35 WAS USED FOR THE SURGERY. IT WAS SMOOTH WHEN IT WAS FIRST INSERTED AND USED NORMALLY. AFTER A PERIOD OF PLACEMENT, THE GUIDEWIRE WAS INSERTED AGAIN. THE GUIDEWIRE WAS RELATIVELY DRY. THE CLINICAL GUIDEWIRE WAS ACTIVATED AGAIN WITH SALINE INJECTION, BUT THE GUIDEWIRE STILL FELT UNLUBRICATED, AND THE GUIDEWIRE COATING FELL OFF. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH THE USE OF THE GUIDEWIRE, BUT THE GUIDEWIRE WAS DIFFICULT TO INSERT, AND THE SURGERY TIME WAS PROLONGED DUE TO ITS NON-SMOOTHNESS. THE UNIT HAS BEEN USING 150NFS35 FOR A LONG TIME. ACCORDING TO CLINICAL FEEDBACK, THE SECOND INSERTION OF THE GUIDEWIRE WAS OCCASIONALLY NOT SMOOTH, WHICH HAS SOME IMPACT ON CLINICAL SURGERY AND PROLONGED SURGERY TIME. ADHERENCE TO THE GUIDEWIRE RESULTED IN SUCCESSFUL COMPLETION OF THE PROCEDURE, BUT DIFFICULTY IN PLACEMENT AND PROLONGATION OF THE PROCEDURE DUE TO THE NON-SMOOTHNESS OF THE GUIDEWIRE.

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

  MAUDE report 21927107 ↗
• MalfunctionApr 23, 2025Expiration Date Error; Wrong Label; Expiration Date Error; Wrong Label

  IT WAS REPORTED THAT THE WAREHOUSE MANAGER DISCOVERED THAT THE EXPIRATION DATES CORRESPONDING TO DIFFERENT PRODUCTION DATES ON THE GUIDE WIRE OUTER PACKAGING WERE DIFFERENT, AND THE EXPIRATION DATE OF THE ONE WITH A LATER PRODUCTION DATE WAS LONGER, SEE THE PICTURE FOR COMPARISON. THEY QUESTIONED WHETHER THE GOODS WERE WRONG AND SOUGHT AN EXPLANATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21890708 ↗
• MalfunctionApr 2, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE GUIDEWIRES AT THE END WAS BENT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 19MAR2025, STATED THAT THERE WAS NO PATIENT IMPACT. THERE WAS NO NEED FOR MEDICAL OR SURGICAL INTERVENTION. THERE WAS NO EXPOSURE OF BLOOD OR BODILY FLUID. ALSO, CUSTOMER CONFIRMED THAT 2 PRODUCTS WERE AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751314 ↗
• MalfunctionMar 17, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT AFTER INSERTING THE NITINOL GUIDEWIRE AND THE STENT INTO THE RENAL PELVIS, DURING THE PROCESS OF PULLING OUT THE GUIDEWIRE, IT WAS FOUND THAT THE FRONT END OF THE GUIDEWIRE WAS SEVERELY KNOTTED AND COULD NOT BE WITHDRAWN. THE SOLUTION WAS TO FIRST WITHDRAW THE STENT, THEN OPERATE BACK AND FORTH UNDER THE MIRROR, STRAIGHTEN THE GUIDEWIRE AND THEN INSERT THE CATHETER. THE WHOLE PROCESS LASTED A RELATIVELY LONG TIME. SURGERY TAKES 30 PERCENTAGE LONGER THAN IT SHOULD, ADDING TO THE WORKLOAD OF THE OPERATOR AND ANESTHESIOLOGIST.

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

  MAUDE report 21617989 ↗
• MalfunctionAug 13, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT PRIOR TO STONE SURGERY, THE PACKAGE WAS OPENED AND BLISTERS WERE FOUND INSIDE THE GUIDEWIRE PACKING TUBE, WHICH WAS ABANDONED. THE GUIDEWIRE WAS REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19972698 ↗
• MalfunctionJun 14, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE URETEROSCOPIC LITHOTRIPSY PROCEDURE, WHEN TRYING TO USE A GUIDEWIRE TO PLACE THE URETEROSCOPE, THE GUIDEWIRE PACKAGE WAS OPENED, AND IT WAS OBVIOUS THAT THE SHEATH WAS DETACHED. THEY GOT A NEW GUIDE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19536798 ↗
• MalfunctionJun 13, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE URETEROSCOPIC LITHOTRIPSY PROCEDURE, WHEN TRYING TO USE A GUIDEWIRE TO PLACE THE URETEROSCOPE, THE GUIDEWIRE PACKAGE WAS OPENED, AND IT WAS OBVIOUS THAT THE SHEATH WAS DETACHED. THEY GOT A NEW GUIDE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19530440 ↗
• MalfunctionFeb 8, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE GUIDE WIRE WAS DAMAGED DURING DISASSEMBLY AND COULD NOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668870 ↗
• MalfunctionNov 30, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE GUIDEWIRE BROKE WHILE IT WAS ADVANCED INSIDE THE PATIENT'S BODY AND THE BROKEN GUIDEWIRE WAS REPLACED WITH A NEW GUIDEWIRE. AFTER THE BREAK, IT WAS CLAMPED OUT WITH FORCEPS, AND THERE WAS NO ADVERSE REACTION FOR THE TIME BEING. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 17NOV2023, STATED THAT THE BROKEN GUIDEWIRE HAS BEEN SENT TO THE PATIENT FOR REMOVAL, AND IT HAS BEEN CLAMPED OUT LITTLE BY LITTLE WITH A CLIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236621 ↗
• MalfunctionOct 9, 2023Flaked; Flaked

  IT WAS REPORTED THAT ONCE THE PACKAGE WAS OPENED, THE GUIDE WIRE WAS SEEN WITH COATING COMING OFF. IT WAS IMPOSSIBLE TO CONTINUE USING THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17895049 ↗
• 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 "IMPACTED STONE, CHANGED TO ANGLE TIP" IN RELATION TO THE NITINOL GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17651829 ↗
• MalfunctionAug 24, 2023Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT THE GUIDEWIRE STICKS TO DOUBLE J STENT WHILE OPERATING AND SO FAILS OUR PROCEDURE AND MAKES BIG PROBLEM DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17611101 ↗
• MalfunctionAug 21, 2023Flaked; Flaked

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE OF THE GUIDE WIRE, THE CORE WAS FOUND EXPOSED AND THE EXTERNAL LAYER WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17584621 ↗
• MalfunctionFeb 28, 2023Accessory Incompatible; Difficult to Insert; Accessory Incompatible; Difficult to Insert

  IT WAS REPORTED THAT THE CUSTOMER UNDERWENT URETERORENOLITHOTRIPSY PROCEDURE ON (B)(6) 2023. FOR THIS PROCEDURE, THE GUIDEWIRE WAS USED. WHEN OPENING THE GUIDEWIRE FOR THE FIRST USE, THEY DID NOT OBSERVE ANYTHING UNUSUAL. IN THE LAST STEP, WHICH WAS THE PLACEMENT OF THE DOUBLE J, A GREAT DEAL OF RESISTANCE WAS NOTICED, THE GUIDE WIRE WAS WETTED AS INSTRUCTED AND EVEN SO, THE DOUBLE J DID NOT PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16451978 ↗
• MalfunctionFeb 24, 2023Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE GUIDEWIRE DID NOT SEEM TO BE HYDROPHILIC AS IT DID NOT MOVED FORWARD. THE CUSTOMER TRIED 2 DEVICES OF THE SAME LOT BUT THE GUIDEWIRES DID NOT MOVE FORWARD . IT WAS STATED THAT THEY WERE BLOCKED AND IT LOOKED LIKE THAT THEY WERE NOT HYDROPHILIC AS IT SHOULD BE . AS PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 13FEB2023, STATED THAT IT WAS NOT POSSIBLE TO SLIDE A URETER CATHETER OVER THE LINING WIRE IN QUESTION. INITIALLY THE USER THOUGHT OF A STENT PROBLEM, BUT THE SECOND STENT GAVE THE SAME PROBLEM, DID NOT SLIDE UP. THEN THE USER REPLACED THE LINER WIRE WITH A NEW ONE AND NOW THE STENT DID SLIDE UP SMOOTHLY. THE LINING WIRE FELT REMARKABLY STIFF/DRY. EVEN AFTER MOISTENING, IT WAS NOT SMOOTH AS IT SHOULD BE. AFTERWARDS THE USER LOOKED AT THAT PARTICULAR LINING WIRE AGAIN, THERE WERE NO VISIBLE DEFECTS, JUST NOTICEABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16436519 ↗
• MalfunctionMay 19, 2022Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE GUIDEWIRE WAS NOT HYDROPHILIC EVEN AFTER WETTING. IT WAS ALSO STATED THAT THE SURFACE WAS TACKY AND NOT SLICK AS DESIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14435124 ↗
• MalfunctionApr 25, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE OPERATION WAS SCHEDULED TO BE PERFORMED ON (B)(6) 2022, BUT WHEN THE PACKAGE WAS OPENED, THE NITINOL GUIDEWIRE WAS FOUND TO BE UNSEALED. THEREFORE, A NEW GUIDEWIRE WAS USED TO COMPLETE THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192714 ↗
• MalfunctionDec 27, 2021Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE INNER PACKAGE OF THE GUIDEWIRE LEAKED AIR AND WAS NOT USED ON THE PATIENT. IT WAS REPLACED WITH A NEW GUIDEWIRE. PER FOLLOW UP VIA IBC IN 04JAN2022, THE PACKAGE WAS NOT SEALED AND THE GUIDE WIRE WAS INTACT BUT NOT STERILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13091121 ↗
• MalfunctionDec 22, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE NITINOL GUIDEWIRE WAS KINKED WHILE USING. CUSTOMER BELIEVED IT WAS COMPROMISED BY A LASER FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13059931 ↗
• MalfunctionDec 5, 2021Flaked; Flaked

  IT WAS REPORTED THAT THE COATING FLAKED OFF AT THE TIP AND THE BODY OF THE GUIDEWIRE. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 23NOV2021, STATED THAT THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12931373 ↗
• MalfunctionAug 24, 2021Flaked; Flaked

  IT WAS REPORTED THAT WHEN THE PACKAGE WAS OPENED, THE COATING OF THE GUIDE WIRE TIP WAS FOUND SHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12363541 ↗
• MalfunctionMay 30, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN THE NURSE OPENED THE GUIDE WIRE FROM BRIGHT RED THE FRONT END OF THE GUIDE WIRE WAS FOUND TO BE BENT AND THE STEEL WIRE WAS EXPOSED. THE GUIDE WIRE WAS REPLACED IMMEDIATELY AND THE PATIENT WAS NOT AFFECTED. PER FOLLOW UP RECEIVED VIA IBC ON 26MAY2021 IT WAS STATED THAT THE BENT WIRE HAVE CAUSED THE WIRE TO STICK OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905866 ↗
• InjuryApr 23, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT WHEN PREPARING THE IMPLANTATION OF TWO NEW STENTS TO THE EVERGREEN I (BDPI-19-003) STUDY PATIENT DE01-027, THE BARD NICORE GUIDEWIRE COULD NOT PASS BOTH PROXIMAL URETERS BECAUSE OF STRONG STRICTURES AND KINKING OF THE URETERS. IN BOTH ATTEMPTS THE GUIDEWIRE TIP PERFORATED THE URETERS, HOWEVER THERE WAS NO SERIOUS DAMAGE. THE PATIENT RECEIVED PERCUTANEOUS NEPHROSTOMIES INSTEAD AND FINALLY ON (B)(6) 2020 ANTEGRADE MONO-J-STENTS. IT WAS STATED THAT THE REPORT DID NOT MENTION THAT THE GUIDEWIRE WAS FAULTY. THE LEFT URETER WAS ALSO PERFORATED BY AN URETEROSCOPY.

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

  MAUDE report 11718478 ↗
• MalfunctionMar 23, 2021Flaked; Flaked

  IT WAS REPORTED THAT BARD NITINOL GUIDEWIRES COATING WAS FALLING OFF THE SURFACE AFTER THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11554091 ↗