SensorRecalls & reported problems across all models

We found 7 models of Sensor by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 193 adverse event reports in the FDA's MAUDE database, received between Jun 28, 2017 and Sep 30, 2026 — classified as 38 injuries, 155 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (98 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Sensor problems

Sensor models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Sensor M0066703080

  STYLET FOR CATHETER, GASTRO-UROLOGY
  118 reports
• Sensor M0066703050

  STYLET FOR CATHETER, GASTRO-UROLOGY
  41 reports
• Sensor M0066703120

  STYLET FOR CATHETER, GASTRO-UROLOGY
  17 reports
• Sensor M0066703090

  STYLET FOR CATHETER, GASTRO-UROLOGY
  11 reports
• Sensor M0066703010

  STYLET FOR CATHETER, GASTRO-UROLOGY
  3 reports
• Sensor M0066703060

  STYLET FOR CATHETER, GASTRO-UROLOGY
  2 reports
• Sensor M0066703100

  STYLET FOR CATHETER, GASTRO-UROLOGY
  1 report

Recent Sensor adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  It was reported that a Sensor Wire was used during cystoscopic ureteric catheterisation. During procedure, the surgeon said that the metal helical coil stripped off from the nitinol core. 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 50946275 ↗
• MalfunctionSep 16, 2026Nonstandard Device; Unraveled Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787501 ↗
• MalfunctionJul 6, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE STENT PLACEMENT PROCEDURE, A SENSOR WIRE WAS USED. IT WAS FOUND THAT THE COATING WAS OBSERVED TO BE PEELED ON THE PROXIMAL HANDLE SIDE PORTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE ANALYSIS OF THE RETURNED DEVICE IDENTIFIED SLEEVE DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25725488 ↗
• MalfunctionMay 26, 2026Nonstandard Device; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A URETERIC STONE REMOVAL PROCEDURE, A SENSOR WIRE WAS USED. WHEN THE PHYSICIAN ADVANCED THE STENT ON THE GUIDE WIRE THE DISTAL TIP COATING CAME OFF. ANOTHER NEW DEVICE WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THE ANALYSIS OF THE RETURNED DEVICE IDENTIFIED SLEEVE DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25292747 ↗
• MalfunctionMay 14, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT AFTER UNPACKING A SENSOR WIRE, THERE WAS A FOREIGN BODY IN THE PACKAGE. 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 25178935 ↗
• MalfunctionApr 13, 2026Break

  IT WAS REPORTED THAT A SENSOR WIRE WAS USED DURING SURGICAL PROCEDURE. DURING PROCEDURE, IT WAS FOUND THAT THE STRAIGHT TIP SENSOR WIRE BLACK FLEXIBLE TIP BROKE OFF. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24857428 ↗
• MalfunctionMar 31, 2026Break; Nonstandard Device; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A TRANSURETHRAL LASER LITHOTRIPSY PROCEDURE, A SENSOR WIRE WAS USED. WHILE THE GUIDEWIRE WAS INSIDE THE PATIENT, THE PTFE COATING WAS OBSERVED TO HAVE PEELED OFF. THE ANALYSIS OF THE RETURNED DEVICE IDENTIFIED CORE WIRE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24749910 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A SENSOR WIRE WAS USED DURING A URETEROSCOPY PROCEDURE. DURING PROCEDURE, THE WIRE BROKE IN THE BLADDER, AND THEY SUCCESSFULLY RETRIEVED THE PIECES LEFT. 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 24635509 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗
• 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 ↗

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