Sensor M0066703120Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729376385), received between Mar 15, 2018 and Sep 16, 2026 — classified as 3 injuries, 14 malfunctions.

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

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Nonstandard Device; Unraveled Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787501 ↗
• MalfunctionMar 30, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A RIGHT LASER URETEROSCOPY PROCEDURE, THE SCRUB NURSE NOTICED A JELLY LIKE CLEAR GLOB ON THE DISTAL END OF THE SENSOR WIRE INSIDE THE STERILE PACKAGING. THE GUIDEWIRE WAS NOT USED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709074 ↗
• MalfunctionFeb 20, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE, THE WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21428482 ↗
• MalfunctionAug 13, 2024Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A GREENLIGHT VAPORIZATION OF THE PROSTATE PROCEDURE USING A SENSOR WIRE, THE COATING WAS FALLING APART AT THE DISTAL PART LEADING THE GUIDEWIRE NOT TO WORK WELL, AND THE PROCEDURE WAS NOT COMPLETED DUE TO THE PATIENT'S STENOSIS THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT IS BEING REPORTED FOR AN ABORTED PROCEDURE WITH A PATIENT UNDER SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977895 ↗
• MalfunctionApr 30, 2024Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING URETEROSCOPY PROCEDURE WHEN THE GUIDEWIRE WAS REMOVED THROUGH THE SCOPE, THE BLUE COATING PEELED OFF. THE GUIDEWIRE AND CHUCK OF THE COATING WERE SUCCESSFULLY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED DETACHED SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19218100 ↗
• MalfunctionNov 18, 2022Break; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Break; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR WIRE WAS USED DURING A URETEROSCOPY PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, THE COREWIRE TIP BROKE AND PUT A HOLE IN NON BOSTON SCIENTIFIC SCOPE THE PROCEDURE WAS COMPLETED WITH A NEW SENSOR WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15825244 ↗
• MalfunctionSep 8, 2022Detachment 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 URETEROSCOPY PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE THE SHRINK SLEEVE DETACHED. THE PROCEDURE WAS COMPLETED WITH THE SAME ORIGINAL GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15379439 ↗
• InjuryAug 16, 2022Detachment 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 URETEROSCOPY PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, THE SHRINK SLEEVE WAS DETACHED. THE DETACHED PORTION WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME ORIGINAL GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15237427 ↗
• MalfunctionMay 19, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR WIRE WAS USED DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE DEVICE WAS OPENED, AN ORANGE PIECE OF PLASTIC WAS FOUND INSIDE THE PACKAGING. THE PROCEDURE WAS COMPLETED WITH A NEW SENSOR WIRE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11849635 ↗
• MalfunctionOct 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR WIRE WAS USED IN THE BLADDER, URETER AND KIDNEY DURING A URETEROSCOPY (URS) PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN GUIDEWIRE WAS PLACED IN THE BLADDER AND URETER INTO KIDNEY, IT WAS NOTED APPROXIMATELY THE LAST FIVE INCHES OF THE SHRINK SLEEVE DETACHED. THE PROCEDURE WAS COMPLETED WITH A NEW SENSOR WIRE GUIDEWIRE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10621874 ↗
• MalfunctionJul 23, 2020Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR WIRE GUIDEWIRE WAS USED IN THE KIDNEY DURING A FLEXIBLE URETEROSCOPY PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE SENSOR WIRE OUTER COVERING OF THE DISTAL END WAS PEELED AND SPLIT EXPOSING THE COREWIRE. THE WIRE WAS REMOVED AND PROCEDURE WAS COMPLETED WITH A NEW SENSOR WIRE GUIDEWIRE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: SHRINK SLEEVE DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10313312 ↗
• InjuryMar 30, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR GUIDEWIRE WAS USED IN THE URETER DURING URETEROSCOPY PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE COREWIRE OF THE GUIDEWIRE BROKE INSIDE THE URETER. THE PHYSICIAN WAS ABLE TO RETRIEVE THE DETACHED PORTION. THE PROCEDURE WAS COMPLETED WITH A NEW SENSOR GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9899288 ↗
• MalfunctionFeb 24, 2020Break; Unraveled Material; Break; Unraveled Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR GUIDEWIRE WAS USED IN THE BLADDER AND URETHRA DURING CYSTOSCOPY PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE COILING SURROUNDING THE WIRE SEPARATED AND THE COREWIRE BROKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9745090 ↗
• MalfunctionFeb 24, 2020Break; Unraveled Material; Break; Unraveled Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR GUIDEWIRE WAS USED IN THE BLADDER AND URETHRA DURING CYSTOSCOPY PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE COILING SURROUNDING THE WIRE SEPARATED AND THE COREWIRE BROKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9745065 ↗
• MalfunctionJan 15, 2020Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR WIRE GUIDEWIRE WAS USED DURING A PROCEDURE ON (B)(6) 2019 ACCORDING TO THE COMPLAINANT, THE GUIDEWIRE COATING WAS PEELED. THE PROCEDURE WAS COMPLETED WITH THIS GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: SHRINK SLEEVE DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9591349 ↗
• MalfunctionApr 11, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR GUIDEWIRE WAS USED IN A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE TIP OF THE WIRE BROKE OFF. THE PROCEDURE WAS COMPLETED WITH A NEW SENSOR GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 Known Impact Or Consequence To Patient

  MAUDE report 8503113 ↗
• InjuryMar 15, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR GUIDEWIRE WAS USED IN THE RIGHT KIDNEY DURING A CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE WHEN THEY WERE PERFORMING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL), THIS SENSOR GUIDEWIRE WAS PASSED DOWN. THE DISTAL COATING SEEMED TO DISSOLVE AND THE WIRE THAT WAS LEFT WAS SHREDDED AND BROKE INTO PIECES. ONE PIECE BROKE OFF, A 4.5 CENTIMETERS LONG AND RETAINED WAS IN THE PATIENT THEY TRIED TO RETRIEVE IT BUT THERE WAS TOO MUCH BLOOD IN THE KIDNEY. THEY HELD OFF THE RETRIEVAL FOR A WEEK UNTIL THE PATIENT DID SOME HEALING AND THEN WENT BACK TO GET IT. REPORTEDLY, "THE DOCTOR DIDN¿T SEEM CONCERNED AT ALL." 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 Known Impact Or Consequence To Patient

  MAUDE report 7343559 ↗