Sensor M0066703060Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729752851), received between Oct 29, 2019 and Jan 12, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, A SENSOR WIRE WAS BEING HANDLED BY THE SURGEON WHEN THE CORE WIRE BROKE OFF. THE GUIDEWIRE BREAK OCCURRED PRIOR TO PATIENT USE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035434 ↗
• MalfunctionOct 29, 2019Break; 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 IN THE URETER DURING A PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE SENSOR WIRE WAS PLACED IN THE URINAL CATHETER. THEN INSERTED IN THE URETHRAL OPENING AND EXPLORED, BLEEDING OCCURRED. THE GUIDEWIRE WAS REMOVED AND EXAMINED. IT WAS NOTED THE COREWIRE TIP WAS BROKEN DUE TO THIS IT SCRATCHED THE URETERAL ORIFICE. REPORTEDLY, NO TREATMENT WAS NEEDED FOR PATIENT FOR BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9252369 ↗