Sensor M0066703090Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729376378), received between Jul 27, 2018 and Feb 27, 2026 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2026Break

  IT WAS REPORTED THAT DURING A CYSTOSCOPY WITH RIGHT LASER LITHOTRIPSY AND SUCTION ASPIRATION OF STONE, RIGHT RETROGRADE PYELOGRAM, AND RIGHT URETERAL STENT PLACEMENT, A SENSOR WIRE WAS USED. THE SURGEON OBSERVED THAT THE SENSOR WIRE HAD BROKEN OFF IN THE KIDNEY. THE BROKEN WIRE WAS SUCCESSFULLY RETRIEVED WITHOUT DAMAGE TO SURROUNDING ANATOMICAL STRUCTURES. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO HARM OCCURRED TO THE PATIENT, AND THE PATIENT RECOVERED AS EXPECTED AND WAS DISCHARGED HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472342 ↗
• MalfunctionJan 30, 2026

  DURING A CYSTOSCOPY WITH RT LASER LITHOTRIPSY AND SUCTION ASPIRATION OF STONE, RT RETROGRADE PYELOGRAM AND RT URETAL STENT, THE SENSOR WIRE WAS NOTED BY THE SURGEON TO HAVE BROKEN OFF IN THE KIDNEY. THE WIRE WAS RETRIEVED WITHOUT DAMAGE TO THE STRUCTURE. CASE CONTINUED WITHOUT FURTHER INCIDENT, NO HARM TO THE PATIENT, PATIENT RECOVERED AND DISCHARGED HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220489 ↗
• MalfunctionJan 7, 2026Break; Nonstandard Device; Unraveled Material

  IT WAS REPORTED THAT, DURING A TRANSURETHRAL LITHOTRIPSY PROCEDURE, A SENSOR WIRE WAS USED, FRAYING WAS OBSERVED ALONG THE LENGTH OF THE GUIDEWIRE, AND A TEAR WAS NOTED IN THE MIDDLE SECTION. IT WAS OBSERVED THAT IT GOT CAUGHT IMMEDIATELY AFTER THE GUIDEWIRE WAS STARTED TO USE. THE GUIDEWIRE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995891 ↗
• MalfunctionNov 10, 2025Nonstandard Device; Difficult to Advance; Nonstandard Device; Difficult to Advance

  IT WAS REPORTED THAT DURING THE PREPARATION, THE PHYSICIAN COMMENTED THAT THE SENSOR GUIDEWIRE WAS NOT SLIDING SMOOTHLY. 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 23513484 ↗
• MalfunctionFeb 13, 2025Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PREPARATION, THE COATING OF THE SENSOR WIRE PEELED. THE PROCEDURE WAS COMPLETED OF ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT INJURY REPORTED. THE DEVICE WAS RETURNED, AND IT WAS IDENTIFIED THAT THE SLEEVE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376979 ↗
• InjuryNov 2, 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 URETEROSCOPY PROCEDURE IN THE URETER OR BLADDER PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE GUIDE WIRE WAS PULLED OUT FROM THE PATIENT, THE BLUE COVERING WAS BROKEN. THE BROKEN PIECE OF THE GUIDEWIRE WAS SUCCESSFULLY RETRIEVED, AND AN X-RAY WAS COMPLETED AT THE END TO ENSURE NOTHING WAS IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE ORIGINAL SENSOR WIRE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE BROKEN PIECE OF WIRE WAS SUCCESSFULLY REMOVED USING GRASPERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18059700 ↗
• InjuryJun 6, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR WIRE WAS USED IN THE KIDNEY DURING AN ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE TIP OF THE SENSOR WIRE BROKE OFF. THE PATIENT WILL REQUIRE ANOTHER PROCEDURE TO REMOVE THE STONE AND THE FRAGMENT THAT BROKE OFF WILL BE RETRIEVED AT THAT TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17070229 ↗
• MalfunctionMay 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR WIRE GUIDEWIRE WAS USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING PROCEDURE, THE SENSOR WIRE SHRINK SLEEVE DETACHED. 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 16920741 ↗
• InjuryNov 23, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SENSOR WIRE GUIDEWIRE WAS USED IN THE KIDNEY AND URETER DURING A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS SENT HOME FROM THE PREVIOUS URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE WITH A PORTION OF THE DETACHED COREWIRE FROM THE SENSOR WIRE. ON (B)(6) 2020 THE PATIENT RETURNED TO THE HOSPITAL SEPTIC. A URETEROSCOPY PROCEDURE WAS PERFORMED ON THE SAME DAY TO REMOVE THE RETAINED FRAGMENT. IT WAS REPORTED THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Unspecified Infection

  MAUDE report 10885833 ↗
• MalfunctionJul 23, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SENSOR WIRE GUIDEWIRE WAS USED DURING A KIDNEY STONE REMOVAL PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SENSOR COREWIRE OF THE GUIDEWIRE BROKE WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW SENSOR WIRE GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10315939 ↗
• MalfunctionJul 27, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR¿ GUIDEWIRE WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION OUTSIDE THE PATIENT, IT WAS NOTICED THAT THERE WAS A FOREIGN OBJECT AT THE TIP OF THE SENSOR GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH A NEW SENSOR¿ GUIDEWIRE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7726349 ↗