BiWire G46138Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00827002461383), received between Apr 8, 2016 and Jun 18, 2026 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2026Peeled/Delaminated

  IT WAS REPORTED PRIOR TO A BILATERAL URETEROSCOPIC EXAMINATION WITH STENT PLACEMENT, THE BIWIRE NITINOL HYDROPHILIC WIRE GUIDE COULD NOT BE ADVANCED THROUGH THE URETEROSCOPE AND "NODULES" WERE FOUND ON THE GUIDEWIRE. THE COATING OF THE WIRE GUIDE WAS NOT ACTIVATED PRIOR TO REMOVING FROM THE HOLDER. THE DEVICE WAS NOT USED AND THE ISSUE WAS DISCOVERED PRIOR TO PATIENT CONTACT. A NEW GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. A PRELIMINARY REVIEW OF THE RETURNED DEVICE SHOWED AREAS OF SKIVED/CUT DAMAGE TO THE POLYMER JACKET MATERIAL, INCLUDING METALLIC CORE WIRE EXPOSURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25545659 ↗
• MalfunctionMar 31, 2026Peeled/Delaminated

  AS REPORTED, A BIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS USED DURING A URETER PROCEDURE TO FACILITATE THE PLACEMENT OF A STENT AFTER CRUSHING THE STONES. IT WAS OBSERVED THAT THE END OF THE WIRE GUIDE HAD A PROTRUSION RESEMBLING A WELDING POINT, WHICH PREVENTED THE STENT FROM PASSING THROUGH THE DEVICE. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE. SUBSEQUENTLY, A DIFFERENT WIRE GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE COATING ON THE DEVICE WAS ACTIVATED PRIOR TO REMOVING THE WIRE GUIDE FROM THE HOLDER, WHICH WAS DONE BY INJECTING WATER INTO THE WIRE GUIDE HOLDER. THE DEVICE WAS USED IN CONJUNCTION WITH AN UNSPECIFIED SHEATH AND AN UNSPECIFIED STENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. AN INVESTIGATION BY THE SUPPLIER REVEALED THAT THE COMPLAINT DEVICE EXHIBITED MULTIPLE AREAS OF SKIVED OR CUT DAMAGE TO THE POLYMER JACKET MATERIAL, ALONG WITH POLYMER JACKET MATERIAL DISPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743570 ↗
• MalfunctionMar 30, 2026Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24730036 ↗
• MalfunctionDec 22, 2025Peeled/Delaminated; Peeled/Delaminated

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865010 ↗
• MalfunctionDec 3, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT BEFORE A KIDNEY STONE PROCEDURE, THE OUTER STERILE PACKAGING OF THE 'BIWIRE NITINOL HYDROPHILIC WIRE GUIDE' SHOWED NO VISIBLE DAMAGE. HOWEVER, ONCE OPENED, THE INNER POUCH WAS FOUND PARTIALLY UNSEALED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE. THE PROVIDED PHOTO SHOWS THE POUCH SEAL OPEN, WITH SEAL IMPRESSIONS VISIBLE ON THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708529 ↗
• MalfunctionOct 21, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE BIWIRE NITINOL HYDROPHILIC WIRE GUIDE BROKE DURING AN UNSPECIFIED PROCEDURE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23351363 ↗
• MalfunctionSep 23, 2025Unsealed Device Packaging; Unsealed Device Packaging

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23125030 ↗
• MalfunctionAug 21, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PACKAGING OF A BIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS NOT SEALED. AFTER OPENING THE OUTER PACKAGING, THE USER OBSERVED THE INNER PACKAGING OF THE DEVICE WAS NOT SEALED. THE USER WAS CONCERNED THE DEVICE WAS CONTAMINATED; THEREFORE, ANOTHER SAME-LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22862638 ↗
• MalfunctionAug 14, 2025Peeled/Delaminated; Peeled/Delaminated

  ADDITIONAL INFORMATION WAS RECEIVED 13OCT2025. NONE OF THE COATING HAD TO BE REMOVED FROM THE PATIENT. THE SCOPE WAS CHECKED FOR DAMAGE AND NO DAMAGE WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22808904 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED A BIWIRE NITINOL HYDROPHILIC WIRE GUIDE¿S TIP WAS FOUND BROKEN PRIOR TO USE IN A FLEXIBLE URETEROSCOPY PROCEDURE. THE ISSUE WAS FOUND UPON OPENING THE PACKAGE PRIOR TO ESTABLISHING PASSAGE UNDER THE UTEROSCOPE. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. A CUSTOMER PROVIDED PHOTO APPEARS TO SHOW THE POLYMER JACKET SEPARATED ON THE TIP. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943215 ↗
• MalfunctionJan 21, 2025Peeled/Delaminated; Peeled/Delaminated

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196722 ↗
• MalfunctionSep 17, 2024Peeled/Delaminated; Peeled/Delaminated

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20243082 ↗
• MalfunctionAug 27, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE 'BIWIRE NITINOL HYDROPHILIC WIRE GUIDES' STERILIZATION PACKAGE CONTAINED A BLACK FOREIGN SUBSTANCE UPON OPENING, PRIOR TO AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20076535 ↗
• MalfunctionJul 10, 2024Peeled/Delaminated; Material Separation; Peeled/Delaminated; Material Separation

  IT WAS REPORTED THE BIWIRE NITINOL HYDROPHILIC WIRE GUIDE'S COATING WAS PEELED OFF PRIOR TO AN UNSPECIFIED PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DEVICE DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19711451 ↗
• MalfunctionJun 21, 2024Peeled/Delaminated; Peeled/Delaminated

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19588743 ↗
• MalfunctionJan 18, 2024Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, DURING TRANSURETHRAL HOLMIUM LASER LITHOTRIPSY OF THE KIDNEYS AND URETERS, THE USER OPENED THE PACKAGE OF BIWIRE NITINOL HYDROPHILIC WIRE GUIDE ON THE OPERATING TABLE AND PREPARED TO USE THE WIRE GUIDE, BUT DISCOVERED THAT THE COATING HAD PEELED OFF. ANOTHER SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18540099 ↗
• MalfunctionJun 13, 2023Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, DURING A FLEXIBLE URETERAL LITHOTRIPSY PROCEDURE, THE COATING OF A 'BIWIRE NITINOL HYDROPHILIC WIRE GUIDE' TIP PEELED OFF AND WAS RETAINED IN THE PATIENTS BLADDER. THE USER USED FORCEPS TO REMOVE THE COATING. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122199 ↗
• MalfunctionFeb 23, 2023Material Separation; Difficult to Advance; Inadequate Lubrication; Material Separation; Difficult to Advance; Inadequate Lubrication

  IT WAS REPORTED THAT THE COATING IN THE MIDDLE OF A BIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS NOT SMOOTH. THE WIRE GUIDE HOLDER FLUSHED WITH SALINE PRIOR TO REMOVING THE WIRE GUIDE FROM THE HOLDER. THE USER DETECTED THE COATING IN THE MIDDLE OF THE WIRE GUIDE WAS NOT SMOOTH WHILE ADVANCING THE WIRE GUIDE. THE USER NOTED RESISTANCE DURING ATTEMPTED ADVANCEMENT AND PLACEMENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO PART OF THE WIRE GUIDE SEPARATED COMPLETELY. ADDITIONAL INFORMATION WAS RECEIVED ON 07FEB2023 NOTING THAT THERE WAS SKIVE/CUT DAMAGE NEAR THE DISTAL ASPECT OF THE WIRE, EXPOSING THE METALLIC CORE WIRE WITH MISSING BLACK POLYMER JACKET MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16432621 ↗
• MalfunctionDec 2, 2022Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, DURING A STONE REMOVAL, AN UNSPECIFIED URETERAL SHEATH WAS ADVANCED DURING THE PROCEDURE AS USUAL AND THE STONE WAS REMOVED. WHILE PLACING AN UNSPECIFIED STENT IT WAS DISCOVERED THAT THE BIWIRE NITINOL HYDROPHILIC WIRE GUIDE HAD NO HYDROPHILIC COATING. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW WIRE GUIDE. INVESTIGATION OF THE RETURNED DEVICE FOUND THE WIRE GUIDE WAS DAMAGED APPROXIMATELY 23.5 CM FROM THE DISTAL TIP EXPOSING THE METAL COILS OF THE WIRE GUIDE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15906187 ↗
• MalfunctionJun 23, 2022Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, DURING A DEVICE PREOPERATIVE EXAMINATION, IT WAS DISCOVERED THAT THE COATING ON A BIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS HAD FALLEN OFF AT THE "SHEATH END." A NEW WIRE GUIDE WAS USED TO COMPLETE THE PROCEDURE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14786710 ↗
• MalfunctionJan 25, 2022Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, DURING PREPARATION PRIOR TO PATIENT CONTACT, A BIWIRE NITINOL HYDROPHILIC WIRE GUIDE'S SURFACE WAS NOT SMOOTH AND HAD A "ROUGH GRANULAR FEELING." THE WIRE GUIDE WAS FLUSHED WITH STERILE LIQUID. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH A NEW WIRE GUIDE. THERE WAS NO IMPACT TO THE PATIENT. UPON SUBSEQUENT EVALUATION OF THE DEVICE, THE METALLIC CORE OF THE WIRE WAS EXPOSED WITH MISSING BLACK POLYMER JACKET MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13343192 ↗
• MalfunctionJul 8, 2021Peeled/Delaminated; Peeled/Delaminated

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12135916 ↗
• MalfunctionJul 19, 2018Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED, INITIALLY THEY STARTED THE URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE USING A RIGID URETEROSCOPE AND THEN SWITCHED TO A FLEXIBLE URETEROSCOPE. AS REPORTED, "DOCTOR WAS BACK LOADING ANGLED END OF THE BIWIRE NITINOL HYDROPHILIC WIRE GUIDE THROUGH THE FLEXIBLE URETEROSCOPE WHEN WIRE GOT STUCK AND WOULD NOT COMPLETELY BACKLOAD THROUGH SCOPE. HE THEN TRIED UNLOADING IT THE OTHER WAY AND COULD NOT DO THAT EITHER, USING A HEMOSTAT, HE WAS ABLE TO PULL THE WIRE OUT FROM THE SCOPE. WE THEN NOTICED THE NITINOL CORE OF THE WIRE GUIDE WAS PROTRUDING FROM THE WIRE OF THE ANGLED END." THE COOK DISTRICT MANAGER ADVISED: THE WIRE CORE WAS STICKING OUT, SO INSTEAD OF THE ANGLED END LOOKING LIKE AN L IT LOOKED MORE LIKE A Y, THE WIRE DID NOT BREAK APART (SEPARATE). ANOTHER SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7702188 ↗
• InjuryApr 8, 2016Material Separation; Material Separation

  DURING A URETEROSCOPY PROCEDURE, THE OUTER SHEATH OF THE WIRE GUIDE SEPARATED WITHIN THE PATIENT AND THE FRAGMENTS WERE SUCCESSFULLY REMOVED VIA INSTRUMENTS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 5564350 ↗