NiCore Nitinol Guidewire 150NSS35Recalls & reported problems

Summary

The FDA's MAUDE database contains 229 adverse event reports that list this exact device (DI 00801741051524), received between Aug 29, 2019 and Aug 4, 2026 — classified as 9 injuries, 220 malfunctions.

The most frequently reported specific device problem is “Flaked” (125 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 229 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2026Flaked

  It was reported that during use on (b)(6) 2025, the patient underwent transurethral ureteroscopy with holmium laser lithotripsy under lumbar anesthesia for ureteral stones. Postoperatively, a hydrophilic guidewire (Bard guidewire) was inserted into the left ureter to guide the ureteroscope into the left ureter. After removing the hydrophilic guidewire, holmium laser lithotripsy was performed. After lithotripsy was completed, a hydrophilic guidewire was reinserted into the left ureter. During use, it was discovered that the hydrophilic coating on the surface of the guidewire had peeled off for no apparent reason, with some of the material falling into the ureter. The guidewire was therefore removed, and the detached hydrophilic material was retrieved piece by piece using stone retrieval forceps. The scope was reinserted, the hydrophilic guidewire was left in place, and F6 double J tubing was placed along the guidewire.

  Patient problems: Foreign Body In Patient

  MAUDE report 50136360 ↗
• MalfunctionJun 26, 2026Flaked

  IT WAS REPORTED THAT, THE PHYSICIAN OPENED THE GUIDEWIRE PACKAGING, REMOVED THE PROTECTIVE CAP FROM THE GUIDEWIRE TIP, AND DISCOVERED THAT THE COATING ON THE TIP HAD PEELED OFF, RENDERING THE GUIDEWIRE UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25643266 ↗
• MalfunctionJun 5, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING USE THE GUIDEWIRE HAD HAIR AT THE FRONT END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410445 ↗
• MalfunctionMay 6, 2026Flaked

  IT WAS REPORTED THAT ON (B)(6) 2026, WHEN THE DOCTOR PLANNED TO PERFORM A RADICAL NEPHROURETERECTOMY ON THE PATIENT, THE USE OF THE GUIDEWIRE REVEALED THAT THE INTERFACE SHOWED THE COATING PEELING OFF. THE GUIDEWIRE WAS THEN REPLACED WITH A NEW ONE TO COMPLETE THE SURGERY, WHICH DID NOT AFFECT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096386 ↗
• MalfunctionApr 3, 2026Flaked; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING THE PROCEDURE THE GUIDEWIRE FACED A MALFUNCTION WHILE PLACING THE GUIDEWIRE ACCORDING TO STANDARD OPERATING PROCEDURES. UPON WITHDRAWAL OF THE GUIDEWIRE, PEELING OF THE GUIDEWIRE SHEATH WAS OBSERVED. THE CLINICAL TEAM COMMUNICATED WITH THE SALES REPRESENTATIVE, STATING THAT THE PRODUCT HAD A QUALITY ISSUE AND NEEDED TO BE SENT TO THE MANUFACTURER FOR TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781659 ↗
• MalfunctionMar 26, 2026Flaked

  IT WAS REPORTED THAT DURING USE THE GUIDEWIRE COATING WRINKLES ON THE HEAD END OF THE CONSUMABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24708529 ↗
• MalfunctionMar 20, 2026Flaked

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING URETEROSCOPIC LITHOTRIPSY WITH A FLEXIBLE URETEROSCOPE, USING A BARD GUIDEWIRE 150NSS35. THE GUIDEWIRE COATING HAD BEEN ACTIVATED, BUT DURING THE PROCEDURE, INTRAOPERATIVELY THE GUIDEWIRE COATING WAS FOUND TO BE PEELING OFF AND WAS VERY ASTRINGENT, WITH FAILURE TO ADVANCE THE BARD URETERAL STENT (B)(6) PROPERLY, REPLACED WITH A NEW GUIDEWIRE, AND THE STENT WAS SUCCESSFULLY PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650668 ↗
• MalfunctionMar 18, 2026Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING A URETEROSCOPIC LASER LITHOTRIPSY PROCEDURE, SALINE WAS INJECTED INTO THE GUIDEWIRE COIL TO ACTIVATE IT. DURING USE, IT WAS DISCOVERED THAT THE GUIDEWIRE SHEATH HAD BURRS AND SUBSEQUENTLY DETACHED; AFTER REPLACEMENT, THE PROCEDURE PROCEEDED SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631556 ↗
• MalfunctionMar 13, 2026Flaked

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT UNDERWENT FLEXIBLE URETEROSCOPY LITHOTRIPSY AND STONE REMOVAL FOR RENAL CALCULI. AFTER INITIAL PLACEMENT OF A GUIDEWIRE AND INSERTION OF A SINGLE-USE URETERAL SHEATH, THE GUIDEWIRE PROVED DIFFICULT TO EXTRACT. UPON REMOVAL, THE GUIDEWIRE SURFACE COATING WAS OBSERVED TO BE PEELED OFF REFER TO ACTUAL SAMPLE AND IMAGE. FOLLOWING CLINICAL ASSESSMENT, A NEW ULTRA-SMOOTH GUIDEWIRE WAS SELECTED, ENABLING SUCCESSFUL COMPLETION OF SUBSEQUENT PROCEDURES. THE SURGERY CONCLUDED WITHOUT COMPLICATIONS. ALTHOUGH SURGICAL AND ANESTHESIA TIMES WERE EXTENDED, NO OTHER ADVERSE EFFECTS OCCURRED. THAT HOSPITAL ROUTINELY USES ULTRA SMOOTH GUIDEWIRES, AND SUCH COATING DETACHMENT WAS INFREQUENT. PATIENT PROCEDURE TIME WAS EXTENDED NO OTHER IMPACTS. A NEW ULTRA-SLIDE GUIDEWIRE WAS SELECTED, AND SUBSEQUENT PROCEDURES WERE COMPLETED SUCCESSFULLY.

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

  MAUDE report 24595767 ↗
• MalfunctionJan 9, 2026Nonstandard Device

  IT WAS REPORTED THAT A PROFESSOR AT THE THIRD AFFILIATED HOSPITAL OF SUN YAT-SEN UNIVERSITY WAS SCHEDULED TO PERFORM A STONE REMOVAL SURGERY ON (B)(6) 2025 BUT FOUND THAT THE TIP OF THE GUIDEWIRE WAS DAMAGED WHEN OPENING THE GUIDEWIRE PACKAGING BEFORE THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24030184 ↗
• MalfunctionDec 29, 2025Flaked; Flaked

  IT WAS REPORTED THAT, UPON UNPACKING THE GUIDEWIRE COATING WAS FOUND DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23914197 ↗
• MalfunctionDec 23, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE EXHIBITED SEVERE PEELING AND BURRING. AFTER REPLACING THE GUIDEWIRE, THE SURGERY WAS COMPLETED. THE PATIENT HAS BEEN EXPOSED TO HARMFUL SUBSTANCES, BLOOD OR BODY FLUIDS.

  Patient problems: Exposure to Body Fluids

  MAUDE report 23882704 ↗
• MalfunctionDec 15, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT, THE FRONT SECTION OF THE GUIDEWIRE WAS ROUGH AND PEELING, RENDERING IT UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810490 ↗
• MalfunctionDec 12, 2025Flaked; Flaked

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE EXHIBITED SEVERE PEELING AND BURRING. AFTER REPLACING THE GUIDEWIRE, THE SURGERY WAS COMPLETED. THE PATIENT HAS BEEN EXPOSED TO HARMFUL SUBSTANCES, BLOOD OR BODY FLUIDS.

  Patient problems: Exposure to Body Fluids

  MAUDE report 23796763 ↗
• MalfunctionDec 10, 2025Flaked; Flaked

  WAS REPORTED THAT, THE FRONT SECTION OF THE GUIDEWIRE WAS ROUGH AND PEELING, RENDERING IT UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23772611 ↗
• MalfunctionDec 10, 2025Flaked; Flaked

  IT WAS REPORTED THAT WHEN OPENED THE GUIDEWIRE PACKAGING, AFTER LUBRICATING WITH STERILE WATER, ONE GUIDEWIRE WAS FOUND TO HAVE A LAYER PEELING OFF THE BODY. AFTER OPENING A NEW PACKAGE OF GUIDEWIRE, THE GUIDEWIRE BODY HAD BURRS; OPENING ANOTHER NEW PACKAGE OF GUIDEWIRE, THE GUIDEWIRE BODY HAD BURRS AND LAYER PEELING. AFTER OPENING ANOTHER NEW PACKAGE OF GUIDEWIRE, THE GUIDEWIRE HAD NO ABNORMALITIES, AND THE SURGERY PROCEEDED SMOOTHLY WITHOUT ANY IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769535 ↗
• MalfunctionNov 26, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT UPON OPENING THE GUIDEWIRE PACKAGING, THE GUIDEWIRE TIP EXHIBITED BENDING AND CREASING AS SHOWN IN THE IMAGE. THIS DID NOT AFFECT THE PATIENT. AFTER USING A NEW GUIDEWIRE, THE PROCEDURE PROCEEDED SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656771 ↗
• MalfunctionOct 3, 2025Material Protrusion/Extrusion; Material Twisted/Bent; Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED THAT FOR THE SAME PATIENT UNDERGOING THE SAME PROCEDURE, AFTER THE GUIDEWIRE WAS USED TO GUIDE THE URETEROSCOPE INTO THE URETER, THE GUIDEWIRE WAS WITHDRAWN. THE SURFACE OF THE GUIDEWIRE BECAME WRINKLED, RENDERING IT UNABLE TO GUIDE STENT PLACEMENT. PATIENT WAS EXPOSED TO BODILY FLUID. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 23210070 ↗
• MalfunctionOct 3, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT AFTER THE GUIDEWIRE GUIDES THE URETEROSCOPE INTO THE URETER, IT BECAME STUCK AND COULD NOT BE ADVANCED FURTHER TO PLACE THE STENT. PATIENT WAS EXPOSED TO BODILY FLUID. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 23210069 ↗
• MalfunctionOct 3, 2025Accessory Incompatible; Difficult to Advance; Accessory Incompatible; Difficult to Advance

  IT WAS REPORTED THAT AFTER GUIDING THE URETEROSCOPE INTO THE URETER, THE GUIDEWIRE BECAME STUCK AND COULD NOT BE ADVANCED FURTHER TO PLACE THE STENT. USER HAS BEEN EXPOSED TO HARMFUL SUBSTANCES, BLOOD OR BODY FLUIDS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 23210068 ↗
• MalfunctionOct 3, 2025Material Protrusion/Extrusion; Material Twisted/Bent; Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED THAT IN THE SAME PATIENT AND THE SAME SURGERY, AFTER THE GUIDEWIRE WAS USED TO GUIDE THE URETEROSCOPE INTO THE URETER, WRINKLES APPEARED ON THE SURFACE OF THE GUIDEWIRE WHEN IT WAS WITHDRAWN, MAKING IT UNABLE TO GUIDE THE STENT IMPLANTATION. USER HAS BEEN EXPOSED TO HARMFUL SUBSTANCES, BLOOD OR BODY FLUIDS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 23210066 ↗
• MalfunctionOct 3, 2025Material Protrusion/Extrusion; Material Twisted/Bent; Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED THAT, AFTER THE GUIDEWIRE WAS USED TO GUIDE THE URETEROSCOPE INTO THE URETER, THE GUIDEWIRE WAS WITHDRAWN. THE SURFACE OF THE GUIDEWIRE BECAME WRINKLED, RENDERING IT UNABLE TO GUIDE STENT PLACEMENT. PATIENT HAS BEEN EXPOSED TO HARMFUL SUBSTANCES, BLOOD OR BODY FLUIDS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 23209384 ↗
• MalfunctionOct 3, 2025Material Protrusion/Extrusion; Material Twisted/Bent; Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED THAT FOR THE SAME PATIENT UNDERGOING THE SAME PROCEDURE, AFTER THE GUIDEWIRE WAS USED TO INTRODUCE THE URETEROSCOPE INTO THE URETER, THE GUIDEWIRE WAS WITHDRAWN. SUBSEQUENTLY, THE GUIDEWIRE SURFACE EXHIBITED WRINKLES AND BECAME ROUGH, RENDERING IT UNSUITABLE FOR GUIDING STENT PLACEMENT. PATIENT WAS EXPOSED TO BODILY FLUID. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 23209203 ↗
• MalfunctionOct 3, 2025Flaked; Flaked

  IT WAS REPORTED THAT, AFTER THE OPERATOR GUIDED THE URETEROSCOPE INTO THE URETER USING A GUIDEWIRE, THE GUIDEWIRE WAS WITHDRAWN. THE PROTECTIVE SHEATH ON THE GUIDEWIRE SURFACE DETACHES, PREVENTING THE STENT FROM BEING GUIDED INTO PLACE. PATIENT HAS BEEN EXPOSED TO HARMFUL SUBSTANCES, BLOOD OR BODY FLUIDS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 23209200 ↗
• MalfunctionSep 29, 2025Flaked; Flaked

  IT WAS REPORTED THAT, THE OPERATOR OPENED THE PACKAGING BOX AND FOUND NO ABNORMALITIES. THE DEVICE WAS PRETREATED WITH SALINE SOLUTION FOR LUBRICATION PRIOR TO USE. IT WAS INSERTED INTO THE BODY TO LOCATE THE PATHWAY. DURING THE PROCEDURE, SOME RESISTANCE WAS FELT. UPON WITHDRAWAL OF THE GUIDEWIRE, IT WAS DISCOVERED THAT THE OUTERMOST COATING HAD PEELED OFF. THE SAMPLE WAS RETAINED BUT WAS BIOLOGICALLY CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23168388 ↗