Autotome RX 49Recalls & reported problems across all models

We found 2 models of Autotome RX 49 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 75 adverse event reports in the FDA's MAUDE database, received between Apr 16, 2018 and Dec 18, 2025 — classified as 75 malfunctions.

The most frequently reported specific device problem is “Break” (62 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 Autotome RX 49 problems

Autotome RX 49 models

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

• Autotome™ RX 49 M00545150

  Unit, electrosurgical, endoscopic (with or without accessories)
  45 reports
• Autotome™ RX 49 M00545160

  Unit, electrosurgical, endoscopic (with or without accessories)
  30 reports

Recent Autotome RX 49 adverse event reports

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

• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SPHINCTEROTOMY WIRE BROKE. IT WAS REPORTED THAT THE DEVICE WAS COMPLETELY AND IMMEDIATELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839685 ↗
• MalfunctionDec 2, 2025Break; 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 AN AUTOTOME RX 49 WAS USED IN A PROCEDURE ON (B)(6) 2025. IT WAS REPORTED THAT AFTER PERFORMING THE SPHINCTEROTOMY, AS THE DEVICE WAS REMOVED, IT WAS NOTICED THAT THE METAL CUTTING WIRE WAS BROKEN. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23698386 ↗
• MalfunctionOct 15, 2025Break; Deformation Due to Compressive Stress; Material Deformation; Break; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT COMMON BILE DUCT STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AN ADVANCEMENT OF THE ENDOSCOPE WAS SMOOTH, AND CANNULATION WAS SUCCESSFUL. CHOLANGIOGRAPHY WAS PERFORMED, BUT DURING THE PROCESS OF FORMING THE BOW, THE CUTTING WIRE WAS FRACTURE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED BY THE COMPLAINANT WHERE IT CAN BE OBSERVED THAT THE CUTTING WIRE WAS BROKEN AND KINKED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME RX 49. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23287599 ↗
• MalfunctionSep 22, 2025Break; 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 AN AUTOTOME RX 49 WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILIARY TRACT LITHOTOMY PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE OF THE TIP WAS FRACTURED DURING THE INCISION OF THE PAPILLA OF THE DUODENAL SPHINCTER. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME RX 49. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23113748 ↗
• MalfunctionSep 12, 2025Break; 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 AN AUTOTOME RX 49 WAS ATTEMPTED TO BE USED IN THE INTESTINAL TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, NORMAL INTUBATION WAS PERFORMED. WHILE CUTTING THE PAPILLA WITH THE GENERATOR ENERGIZED, THE CUTTING WIRE BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23044106 ↗
• MalfunctionAug 12, 2025Failure to Conduct; Material Deformation; Adverse Event Without Identified Device or Use Problem; Failure to Conduct; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE CONTACT WAS POOR AND THE POWER SUPPLY WAS NOT CONTINUOUS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF DEVICE CUTTING WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786322 ↗
• MalfunctionMay 23, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT A COMMON BILE DUCT STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, CHOLEDOCHOGRAPHY WAS PERFORMED AFTER SUCCESSFUL INSERTION OF THE ENDOSCOPE AND INTUBATION. UPON BOWING THE DEVICE, THE CUTTING WIRE OF THE AUTOTOME RX 49 BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THE IMAGING PHOTO INSIDE THE PATIENT SHOWS THAT THE CUTTING WIRE WAS BROKEN. A PHOTO OF THE DEVICE OUTSIDE THE PATIENT ALSO SHOWS THE CUTTING WIRE WAS BROKEN AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076052 ↗
• MalfunctionMay 16, 2025Failure to Align; Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS ATTEMPTED TO BE USED IN A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS REPORTED THAT AFTER THE DEVICE ENTERED THE PATIENT, THE AUTOTOME RX 49 DID BOW CORRECTLY BUT WOULD NOT RELEASE THE BOW. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22037962 ↗
• MalfunctionNov 14, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT AN AUTOTOME RX 49 WAS CHECKED AFTER BEING RECEIVED IN A BSC WAREHOUSE. THE EXACT DATE OF THE EVENT IS UNKNOWN. FOREIGN MATERIAL WAS FOUND INSIDE THE UNOPENED POUCH OF THE DEVICE. IT WAS REPORTED THAT THE STERILE SEAL WAS NOT COMPROMISED, AS ALL PACKAGING SEALS WERE INTACT. THERE WAS NO HEALTHCARE FACILITY, PROCEDURE OR PATIENT INVOLVED IN THIS EVENT. NOTE: PHOTOS OF THE COMPLAINT DEVICE WERE PROVIDED AND SHOWED FOREIGN MATERIAL INSIDE THE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685066 ↗
• MalfunctionNov 14, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT AN AUTOTOME RX 49 WAS CHECKED AFTER BEING RECEIVED IN A BSC WAREHOUSE. THE EXACT DATE OF THE EVENT IS UNKNOWN. FOREIGN MATERIAL WAS FOUND INSIDE THE UNOPENED POUCH OF THE DEVICE. IT WAS REPORTED THAT THE STERILE SEAL WAS NOT COMPROMISED, AS ALL PACKAGING SEALS WERE INTACT. THERE WAS NO HEALTHCARE FACILITY, PROCEDURE OR PATIENT INVOLVED IN THIS EVENT. NOTE: PHOTOS OF THE COMPLAINT DEVICE WERE PROVIDED AND SHOWED FOREIGN MATERIAL INSIDE THE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684909 ↗
• MalfunctionOct 18, 2024Break; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Break; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE WAS BROKEN. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME RX 49. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THE COMPLAINANT REPORTED THAT THE DEVICE WAS ENERGIZED PRIOR TO BOWING. HOWEVER, ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), PRECAUTION: THE SPHINCTEROTOME DOES NOT NEED TO BE ENERGIZED PRIOR TO PERFORMING SPHINCTEROTOMY. ENERGIZING THE CUTTING WIRE PRIOR TO USE WILL CAUSE PREMATURE CUTTING WIRE FATIGUE AND WILL COMPROMISE THE CUTTING WIRE'S INTEGRITY. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 21, 2024: IT WAS REPORTED THAT THE DEVICE WAS NOT ENERGIZED PRIOR TO BOWING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20482231 ↗
• MalfunctionJul 15, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A AUTOTOME RX 49 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH CHOLEDOCHOLITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHILE CUTTING THE PAPILLA, THE CUTTING WIRE SUDDENLY GOT FRACTURED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: A PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWED THE CUTTING WIRE WAS BROKEN AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19737885 ↗
• MalfunctionJul 11, 2024Break; 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 AN AUTOTOME RX 49 WAS USED IN THE DUODENAL PAPILLA DURING A BILIARY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE INCISION OF THE PAPILLA WAS PERFORMED, THE CUTTING WIRE SEPARATED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19718481 ↗
• MalfunctionMay 17, 2024Break; 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 AN AUTOTOME RX 49 WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC PAPILLOTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE OF THE RX 49 BROKE OFF AFTER STEPPING ON THE FOOT PEDAL SEVERAL TIMES DURING AN ATTEMPT TO PERFORM A PAPILLOTOMY. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19338475 ↗
• MalfunctionApr 1, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 49 WAS USED IN THE DISTAL BILE DUCT DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CUTTING WIRE OF THE AUTOTOME RX 49 BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19016341 ↗

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