Sensor M0066703050Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 08714729376354), received between Jan 30, 2018 and Mar 26, 2026 — classified as 6 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (28 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Unsealed Device Packaging

  IT WAS REPORTED THAT SEAL OF SENSOR WIRE PACKAGE WAS NOTED TO BE PEELED OFF BUT THERE WAS NO DAMAGE NOTED ON THE OUTER CARTON. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701954 ↗
• InjuryFeb 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, THE PATIENT'S URETER WAS PERFORATED, ATTRIBUTED TO THE SENSOR WIRE. THE PHYSICIAN NOTED THIS HAPPENED WITH ANOTHER OF THE SAME LOT NUMBER. THE PHYSICIAN FELT DIFFERENT, THE WIRE WAS DARKER BLUE, SHINIER, THINNER, AND MORE SLIPPERY THAN NORMAL, WITH NO RIGIDITY OR VISIBLE LINES ON THE VIDEO TOWER, WHICH CONTRIBUTED TO THE PERFORATION AND PATIENT COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITH A SENSOR WIRE FROM A DIFFERENT LOT NUMBER OBTAINED FROM STONY BROOK MAIN HOSPITAL, WHICH APPEARED NORMAL IN APPEARANCE AND FEEL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24256896 ↗
• InjuryDec 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, THE PATIENT'S URETER WAS PERFORATED, ATTRIBUTED TO THE SENSOR WIRE. THE PHYSICIAN NOTED THIS WAS NOT THE FIRST OCCURRENCE WITH THE SAME LOT NUMBER. HE DESCRIBED THE WIRE AS DARKER BLUE, SHINIER, THINNER, AND MORE SLIPPERY THAN NORMAL, WITH NO RIGIDITY OR VISIBLE LINES ON THE VIDEO TOWER. IN HIS OPINION, THE OUTER COATING WAS MISSING, WHICH CONTRIBUTED TO THE PERFORATION AND PATIENT COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITH A SENSOR WIRE FROM A DIFFERENT LOT NUMBER OBTAINED FROM STONY BROOK MAIN HOSPITAL, WHICH APPEARED NORMAL IN APPEARANCE AND FEEL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23790543 ↗
• MalfunctionDec 8, 2025Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE TRANSURETHRAL LITHOTOMY PROCEDURE, WHEN UNPACKED IT WAS FOUND THAT THE TIP WAS CRUSHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED. THE ANALYSIS OF THE RETURNED DEVICE IDENTIFIED SLEEVE DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23742701 ↗
• MalfunctionDec 4, 2025Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE, THE PHYSICIAN ATTEMPTED TO CREATE A TRACT FROM THE SKIN INTO THE PATIENT'S KIDNEY USING A CHIBA TIP NEEDLE AND A SENSOR GUIDE WIRE. THE PHYSICIAN ATTEMPTED TWICE BUT WAS UNABLE TO ACCESS THE KIDNEY. ON THE THIRD ATTEMPT, UNDER FLUOROSCOPY, A BLACK LINE WAS OBSERVED WITHIN THE PATIENT'S ABDOMINAL REGION. THE PHYSICIAN WAS UNCERTAIN OF ITS EXACT LOCATION AT THAT TIME. THE SENSOR GUIDEWIRE WAS WITHDRAWN, AND UPON INSPECTION, THE PHYSICIAN NOTED THAT THE HYDROPHILIC TIP WAS PARTIALLY MISSING. A DIFFERENT NON-BOSTON SCIENTIFIC HYDROPHILIC GUIDE WIRE WAS THEN USED; HOWEVER, DUE TO PROCEDURAL DIFFICULTY, ACCESS TO THE KIDNEY COULD NOT BE ACHIEVED AND THE PROCEDURE WAS NOT COMPLETED. THE PHYSICIAN PLANNED TO REOPERATE ON THE PATIENT AT A LATER DATE TO REMOVE THE RETAINED PORTION OF THE GUIDE WIRE TIP. THE INTERVENTION PLAN FOR RETRIEVAL WAS PERFORMED, AND THE DETACHED TIP WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717112 ↗
• MalfunctionNov 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER UNPACKING, IT WAS FOUND THAT THE LOOP FELL OFF. HOWEVER, FURTHER INFORMATION CONFIRMED THAT THE SLEEVE WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23521489 ↗
• MalfunctionNov 10, 2025Break; Peeled/Delaminated; Break; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE USING A SENSOR GUIDEWIRE, THE PHYSICIAN USED A 4.5 FR URETEROSCOPE TO PLACE A DOUBLE-J STENT. FOLLOWING SUCCESSFUL STENT PLACEMENT, THE HYDROPHILIC COATING OF THE GUIDEWIRE DETACHED DURING WITHDRAWAL, CAUSING A SMALL SEGMENT OF THE WIRE TO FRACTURE AND REMAIN INSIDE THE PATIENT. THE PHYSICIAN SUBSEQUENTLY IDENTIFIED AND RETRIEVED THE FRACTURED FRAGMENT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513558 ↗
• MalfunctionOct 20, 2025Nonstandard Device; Detachment of Device or Device Component; Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SENSOR WIRE WAS USED IN A URETEROSCOPY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE SLEEVE WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23343060 ↗
• MalfunctionOct 8, 2025Nonstandard Device; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER COULD NOT BE INSERTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED. ANALYSIS OF THE RETURNED GUIDEWIRE IDENTIFIED THAT THE DISTAL TIP WAS KINKED AND UNRAVELED, AND THE SLEEVE WAS DETACHED FROM THE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23248974 ↗
• MalfunctionJun 30, 2025Break; Nonstandard Device; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Nonstandard Device; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GUIDEWIRE WAS STRETCHED AND FRACTURED. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22357362 ↗
• MalfunctionMar 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE, THE WIRES ARE DIFFERENT. ADDITIONALLY, IT WAS NOTED THAT THE SLEEVE WAS DETACHED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632324 ↗
• MalfunctionMar 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE, THE WIRES ARE DIFFERENT. ADDITIONALLY, IT WAS NOTED THAT THE SLEEVE WAS DETACHED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620725 ↗
• MalfunctionOct 12, 2024Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HAND SIDE PRODUCT OF THE GUIDEWIRE WAS LIFTED AND CAME OFF FROM THE START OF TRANSURETHRAL LITHOTRIPSY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. ANALYSIS OF THE RETUNED DEVICE IDENTIFIED SLEEVE DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20434960 ↗
• InjuryAug 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, A SENSOR WIRE WAS USED. THE GUIDEWIRE WAS BROKEN INTO TWO PIECES, AND IT WAS RETRIEVED. NO PATIENT COMPLICATIONS WERE REPORTED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT AND PROCEDURE OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20070220 ↗
• InjuryMay 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING URETEROSCOPY PROCEDURE WHILE REMOVING THE GUIDEWIRE, THE FLEXIBLE PROXIMAL HEAD OF THE GUIDEWIRE DETACHED IN THE URETER. THE DETACHED PIECE WAS EXTRACTED USING GRASPING FORCEPS. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PROCEDURE AND PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19273853 ↗
• MalfunctionFeb 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR WIRE WAS USED TO TREAT KIDNEY STONES DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2024. AFTER COMPLETION OF THE PROCEDURE SUCCESSFULLY WITH THE SENSOR GUIDEWIRE, WHEN THE PHYSICIAN PERFORMED FINAL CHECK WITH THE URETEROSCOPE, A PLASTIC SHEATH (SLEEVE) OF THE GUIDEWIRE WAS OBSERVED TO BE DETACHED. THE PLASTIC SHEATH WAS REMOVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18654052 ↗
• MalfunctionJan 10, 2024Break; Unraveled Material; Break; Unraveled Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR WIRE WAS USED DURING A URETEROSCOPIC LITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, WHEN THE GUIDEWIRE WAS REMOVED FROM THE ENDOSCOPE, IT WAS FOUND THAT THE OUTER LAYER WAS PEELED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER SENSOR WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE CORE WIRE WAS DETACHED/SEPARATED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18483567 ↗
• MalfunctionOct 11, 2023Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR WIRE WAS USED DURING A FLEXIBLE MIRROR SURGERY TO RETROGRADE INTRARENAL SURGERY PERFORMED ON JUNE 25, 2023. DURING THE PROCEDURE, THE COATING OF THE SENSOR WIRE FELL OFF INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW SENSOR GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF A SECTION OF THE BLUE SLEEVE AT THE PROXIMAL SECTION OF THE SENSOR WIRE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17914218 ↗
• MalfunctionOct 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR WIRE WAS USED DURING A PROCEDURE. THE EXACT EVENT DATE WAS NOT REPORTED. DURING THE PROCEDURE, THE BLUE SOFT PART ON THE PROXIMAL PART OF THE GUIDEWIRE WAS SEPARATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER SENSOR WIRE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17898521 ↗
• MalfunctionOct 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR WIRE WAS USED DURING A PROCEDURE. THE EXACT EVENT DATE WAS NOT REPORTED. DURING THE PROCEDURE, THE BLUE SOFT PART ON THE PROXIMAL PART OF THE GUIDEWIRE WAS SEPARATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER SENSOR WIRE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17898349 ↗
• MalfunctionJul 10, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR WIRE WAS USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. DURING PREPARATION, UPON OPENING THE PACKAGING, A COLORED SUBSTANCE WAS FOUND ON THE HOOP OF THE OF THE SENSOR WIRE. THE PROCEDURE WAS COMPLETED WITH A NEW SENSOR GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17288424 ↗
• MalfunctionJun 5, 2023Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR WIRE WAS USED IN A PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, THE SHRINK SLEEVE DETACHED. NO FURTHER INFORMATION HAS BEEN OBTAINED REGARDING THE PROCEDURE OUTCOME DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17064966 ↗
• MalfunctionFeb 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR WIRE WAS USED DURING AN URETEROLITHOTOMY PROCEDURE ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS REPORTED THE WHOLE COATING PEELED OFF. BASED ON MEDIA THE CUSTOMER PROVIDED IT SHOWS THE SLEEVE ON THE SENSOR WIRE WAS DETACHED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16280649 ↗
• MalfunctionDec 28, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR WIRE GUIDEWIRE WAS USED ON (B)(6) 2022. DURING THE PROCEDURE, THE BLUE PART OF THE DEVICE HAD COME AWAY AND DETACHED FROM THE CORE WIRE BY APPROXIMATELY 10 CM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME SENSOR WIRE GUIDEWIRE THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16064405 ↗
• MalfunctionOct 20, 2022Difficult to Remove; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR WIRE WAS USED DURING A TRANSURETHRAL LITHOTOMY (TUL) PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, THE SENSOR WIRE WAS DIFFICULT TO REMOVE. WHEN THE DEVICE WAS REMOVED, NO DETACHMENT WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A NEW SENSOR WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF SHRINK SLEEVE DETACHED. FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15643287 ↗