Sensor M0066703080Recalls & reported problems

Summary

The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 08714729376361), received between Jun 28, 2017 and Sep 30, 2026 — classified as 24 injuries, 94 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (63 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 118 reports, 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 ↗
• 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 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 ↗
• MalfunctionDec 17, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT, THE SENSOR WIRE WAS FOUND LIFTED AND PEELED OFF AT THE DISTAL TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE NOTED. THE ANALYSIS OF THE RETURNED DEVICE IDENTIFIED SLEEVE DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829112 ↗
• MalfunctionDec 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING THE CYSTOSCOPY, URETEROSCOPY WITH LASER LITHOTRIPSY AND STENT PLACEMENT PROCEDURE, A SENSOR WIRE WAS USED, WHEN THE WIRE WAS REMOVED FROM THE PATIENT, IT WAS OBSERVED THE SLEEVE HAD DETACHED; HOWEVER, THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23809420 ↗
• MalfunctionDec 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TRANSURETERAL LITHOTRIPSY PROCEDURE, WHEN THE DEVICE WAS WITHDRAWN FROM THE LOOP OF THE GUIDEWIRE AND ATTEMPTED TO BE USED, THE FLEX PORTION ON THE PROXIMAL SIDE WAS PEELED OFF OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720652 ↗
• MalfunctionDec 4, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS FOUND THAT, WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING, THE SEAL WAS COMPROMISED. THE DEVICE WAS NOT USED IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23718183 ↗
• MalfunctionNov 28, 2025Break

  DURING PROCEDURE, SURGEON INSERTED A STRAIGHT TIP SENSOR WIRE INTO LEFT URETER THE THAT BROKE OFF. THE BROKEN PIECE WAS VISUALIZED, RETRIEVED AND REMOVED FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23671432 ↗
• MalfunctionNov 24, 2025Nonstandard Device; Peeled/Delaminated; Detachment of Device or Device Component; Nonstandard Device; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING THE STENT REPLACEMENT PROCEDURE USING A SENSOR WIRE, THE DEVICE COATING WAS PEELED OFF. 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 23638982 ↗
• MalfunctionNov 7, 2025Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT, A SENSOR WIRE WILL BE USED IN A FLEXIBLE URETEROSCOPIC LITHOTRIPSY PROCEDURE. UPON UNPACKING, IT WAS FOUND THAT THE GUIDE WIRE WAS FRACTURED IN THE MIDDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, AND NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23503661 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT DURING THE LASER LITHOTRIPSY PROCEDURE, THE WIRE STRIPPED INSIDE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ALTERNATIVE DEVICE, AND THERE WERE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457907 ↗
• MalfunctionOct 23, 2025Nonstandard Device; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE TRANSURETHRAL LITHOTRIPSY PROCEDURE, THE TIP PART GOT SEPARATED WHEN IT WAS INSERTED INTO THE ENDOSCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS. THE ANALYSIS OF THE RETURNED DEVICE IDENTIFIED SLEEVE DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23375622 ↗
• MalfunctionOct 23, 2025Break; Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Break; Nonstandard Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE TRANSURETHRAL LITHOTRIPSY PROCEDURE, THE DEVICE WAS CUT ON THE PROXIMAL SIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A SLEEVE DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23375310 ↗
• MalfunctionOct 3, 2025Nonstandard Device; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DISTAL TIP PEELED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED GUIDEWIRE IDENTIFIED THE SLEEVE WAS DETACHED FROM THE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23207068 ↗
• MalfunctionSep 29, 2025Detachment 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 THAT DURING THE PROCEDURE, UPON REMOVING THE GUIDEWIRE FROM THE PROTECTIVE HOOP, THE BLUE SECTION AT THE HAND END WAS FOUND TO HAVE 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 23173347 ↗
• MalfunctionSep 10, 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 UNPACKING, THE COATING OF THE GUIDEWIRE WAS PEELING OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED GUIDEWIRE IDENTIFIED THE SLEEVE WAS FULLY DETACHED FROM THE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23018647 ↗
• MalfunctionAug 1, 2025Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  T WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT URETERAL METAL STENT PLACEMENT. THE GUIDEWIRE WAS USED TO GUIDE THE CATHETER PLACEMENT. DURING THE PROCEDURE, IT WAS FOUND THAT THE COATING OF THE GUIDEWIRE PEELED OFF. THE USE WAS STOPPED, CAUSING NO IMPACT ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22687749 ↗
• MalfunctionJun 9, 2025Contamination; Use of Device Problem; Contamination; Use of Device Problem

  IT WAS REPORTED THAT THE SENSOR WIRE EXPIRED APRIL 2025. IT WAS USED IN THE PATIENT AFTER EXPIRATION DATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22171966 ↗
• InjuryJun 5, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CYSTOSCOPY, RIGHT RETROGRADE PYELOGRAM, URETEROSCOPIC HOLMIUM LASER LITHOTRIPSY, STONE BASKETING, AND TIGHT URETERAL STENT PLACEMENT. DURING STONE CLEARANCE AND FLUOROSCOPIC EVALUATION OF STONE CLEARANCE PROGRESS, THE WORKING SENSOR WIRE WAS NOT VISUALIZED. A SEPARATE WIRE FRAGMENT WAS SEEN ON FLUOROSCOPY IN THE UPPER POLE. THE WIRE FRAGMENT WAS VISUALIZED AND ATTEMPTS WERE MADE TO RETRIEVE IT USING A ZERO TIP BASKET AND PIRANHA FORCEPS. HOWEVER, RETRIEVAL OF THE BROKEN WIRE FRAGMENT WAS UNSUCCESSFUL. THE PATIENT WAS RETURNED TO THE OPERATING ROOM. A FLEXIBLE URETEROSCOPE WAS ADVANCED INTO THE KIDNEY. PYELOSCOPY WAS PERFORMED. THE RETAINED SENSOR WIRE FRAGMENT WAS IDENTIFIED AND SUCCESSFULLY GRASPED WITH A THREE-PRONG BASKET AND REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22152028 ↗
• InjuryMay 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SENSOR WIRE WAS USED DURING URETEROSCOPY PROCEDURE. THE PHYSICIAN PLACED A SENSOR WIRE INTO THE URETER, LEFT IT IN PLACE, REMOVED THE OLD URETERAL STENT. IT WAS NOTED THAT A PIECE OF THE DISTAL END OF THE SENSOR WIRE HAS SHEARED OFF IN THE BLADDER. THE PIECE WAS 5 INCHES IN LENGTH. THE PHYSICIAN WAS ABLE TO REMOVE THE DETACHED PIECE FROM THE BLADDER. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994985 ↗
• MalfunctionMar 27, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING INSERTION, THE GUIDEWIRE WAS NOT SMOOTH ENOUGH TO USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SLEEVE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21714140 ↗