Autotome RX 39Recalls & reported problems across all models

We found 2 models of Autotome RX 39 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 114 adverse event reports in the FDA's MAUDE database, received between Apr 11, 2017 and May 5, 2026 — classified as 4 injuries, 110 malfunctions.

The most frequently reported specific device problem is “Break” (80 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 39 problems

Autotome RX 39 models

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

• Autotome™ RX 39 M00545190

  Unit, electrosurgical, endoscopic (with or without accessories)
  68 reports
• Autotome™ RX 39 M00545200

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

Recent Autotome RX 39 adverse event reports

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

• MalfunctionMay 5, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILIARY DISEASE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE CUTTING WIRE OF THE AUTOTOME RX 39 BROKE WHEN SPHINCTEROTOMY WAS PERFORMED. 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. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085394 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILIARY DISEASE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE CUTTING WIRE OF THE AUTOTOME RX 39 BROKE WHEN SPHINCTEROTOMY WAS PERFORMED. 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. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085388 ↗
• MalfunctionMay 4, 2026Use of Device Problem; Deformation Due to Compressive Stress; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CUT WIRE WAS BENT AND DIFFICULT TO CANNULATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE TIP LOOKED DEFORMED DURING EVALUATION UPON RECEIPT HOWEVER THE DEVICE WAS STILL USED. PER THE INSTRUCTION FOR USE (IFU), DO NOT USE THE DEVICE IF ANY DEFECT, MALFUNCTION, OR ABNORMALITY IS OBSERVED DURING INSPECTION, AS THIS MAY RESULT IN PATIENT INJURY OR DEVICE FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071923 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CHOLANGITIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUT WIRE BROKE OFF FROM THE TIP OF THE TOME. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25038307 ↗
• MalfunctionApr 25, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUT WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH THE SAME ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24991740 ↗
• InjuryApr 17, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE OF THE SPHINCTEROTOME BROKE OFF INSIDE THE PATIENT WHILE IT WAS IN USE. THE POSITION OF THE BROKEN PIECE INITIALLY PREVENTED THE PHYSICIAN FROM DEPLOYING A PANCREATIC STENT. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING 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 24907113 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT PRIMARY SCLEROSING CHOLANGITIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A SPHINCTEROTOMY WAS PERFORMED. AT THE COMPLETION OF THE CUT, THE PROXIMAL END OF THE EXPOSED CUTTING WIRE SNAPPED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. A PHOTO OF AN UNKNOWN DEVICE WAS PROVIDED AND SHOWED A BROKEN WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24841022 ↗
• MalfunctionMar 30, 2026Break; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2026. DURING THE PROCEDURE, THE CUTTING WIRE BROKE WHEN MAKING THE SPHINCTEROTOMY. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED 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 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 FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716187 ↗
• MalfunctionMar 23, 2026Deformation Due to Compressive Stress; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2025. DURING THE PREPARATION, IT WAS REPORTED THAT THE DEVICE CAME OUT OF THE PACKAGE TWISTED. 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 FULLY RECOVERED. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: THE CUTTING WIRE KINKED. PLEASE REFER TO BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665079 ↗
• MalfunctionMar 20, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN SPHINCTEROTOMY WAS ATTEMPTED, THE CUT WIRE SNAPPED AND 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. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. 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 FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651547 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE BROKE WHEN ENERGIZED WITH CAUTERY. 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 DUE TO THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24479057 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. PRIOR TO THE PROCEDURE, PHYSICIAN WENT TO BEGIN SPHINCTEROTOMY AND ENERGY WAS NOT BEING DELIVERED. UPON BOWING AND UNBOWING, THE PHYSICIAN REALIZED THAT THE CUT WIRE WAS BROKEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401790 ↗
• MalfunctionFeb 15, 2026Break; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE WIRE ANCHOR WAS DISLODGED FROM THE CATHETER UPON SPHINCTEROTOMY. IT WAS REPORTED THAT THE CUTTING WIRE WAS INTACT, AND NO PART OF THE DEVICE WAS DETACHED AND FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION WAS REPORTED TO BE FULLY RECOVERED. ADDITIONAL INFORMATION WAS RECEIVED ON FEBRUARY 12, 2026: IT WAS REPORTED THAT THERE WAS A BREAK IN THE CUTTING WIRE. THE ANATOMY LOCATION WAS THE AMPULLA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24341506 ↗
• MalfunctionFeb 13, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE CUTTING WIRE OF THE AUTOTOME RX 39 BROKE OFF. 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 DUE TO THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332641 ↗
• MalfunctionJan 9, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CUTTING WIRE OF THE AUTOTOME RX 39 BROKE. 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 FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24023233 ↗

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