Autotome RX 44Recalls & reported problems across all models

We found 2 models of Autotome RX 44 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 326 adverse event reports in the FDA's MAUDE database, received between Aug 7, 2017 and Sep 28, 2026 — classified as 1 death, 11 injuries, 314 malfunctions.

The most frequently reported specific device problem is “Break” (213 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

Autotome RX 44 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 12, 2024Class IIOpen, Classified

   Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure.

   Z-2350-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported Autotome RX 44 problems

Autotome RX 44 models

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

• Autotome™ RX 44 M00545170

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall262 reports
• Autotome™ RX 44 M00545180

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 death64 reports

Recent Autotome RX 44 adverse event reports

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

• MalfunctionSep 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923789 ↗
• MalfunctionSep 23, 2026Break; Use of Device Problem; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873537 ↗
• MalfunctionSep 18, 2026Failure to Fold; Deformation Due to Compressive Stress; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831300 ↗
• MalfunctionSep 17, 2026Break; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809545 ↗
• MalfunctionAug 22, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50389934 ↗
• MalfunctionAug 21, 2026Break; Deformation Due to Compressive Stress

  It was reported to Boston Scientific Corporation that an Autotome RX 44 was attempted to be used in the Duodenal Papilla during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure to treat Bile duct stones performed on (b)(6) 2026.During the procedure, the cutting wire was fractured when the direction of the bow was adjusted for the first time. A photo of the complaint device was provided and showed that the cutting wire was broken and kinked. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50360700 ↗
• MalfunctionJul 13, 2026Failure to Align; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS ATTEMPTED TO BE USED IN THE INTESTINAL TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STONE REMOVAL PROCEDURE TO TREAT TRANSDUODENAL ODDI'S SPHINCTEROPLASTY PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN BOWING, THE PLASTIC SHEATH AT THE AUTOTOME TIP WAS KINKED. AS A RESULT, THE CUTTING WIRE COULD NOT BE FULLY STRAIGHTENED. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE WORKING LENGTH WAS KINKED AND THE DEVICE IN A BOWED POSITION. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25807891 ↗
• MalfunctionJul 3, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT COMMON BILE DUCT STONE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THE PHYSICIAN PERFORMED THE SPHINCTEROTOMY USING THE DEVICE, IT WAS NOTED THAT THE CUTTING WIRE OF THE AUTOTOME 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 25708379 ↗
• MalfunctionJun 19, 2026Break; Failure to Conduct

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILE DUCT STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE DEVICE FUNCTIONED NORMALLY ON ITS FIRST USE. HOWEVER, THERE WAS NO RESPONSE WHEN IT WAS ACTIVATED A SECOND TIME, AND REPEATED ATTEMPTS PRODUCED THE SAME RESULT. THE AUTOTOME WAS THEN WITHDRAWN, AND EXAMINATION REVEALED THAT ITS TIP HAD FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST THAT THE CUTTING WIRE BROKE. 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 25566219 ↗
• MalfunctionMay 25, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS USED IN THE PAPILLA DURING A PAPILLO SPHINCTEROTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE CUTTING WIRE BREAK UPON SPHINCTEROTOMY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25272206 ↗
• MalfunctionMay 25, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS PREPARED TO USE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PREPARATION OUTSIDE THE PATIENT, THE PRODUCT WAS UNPACKED AND IT WAS FOUND THAT THE STEEL WIRE INSIDE THE HANDLE WAS FRACTURED. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25271748 ↗
• MalfunctionMay 23, 2026Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS USED DURING A SPHINCTEROTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DEVICE DOES NOT ALLOW THE GUIDEWIRE TO SLIDE. ALSO, THE DISTAL TIP DOES NOT BEND CORRECTLY AND LOSES ITS SHAPE MEMORY. DURING SPHINCTEROTOMY, THE CUTTING WIRE DETACHED FROM THE CATHETER. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25263555 ↗
• MalfunctionMay 5, 2026Break; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS ATTEMPTED TO BE USED ON THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND BILIARY STENT IMPLANTATION PROCEDURE TO TREAT BILE DUCT STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE STEEL WIRE WAS FRACTURED WHEN PULLING OUT THE AUTOTOME. THE CUSTOMER PROVIDED PHOTOS SHOWING THAT THE CUTTING WIRE WAS BROKEN AND KINKED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084758 ↗
• MalfunctionMay 5, 2026Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE GUIDE WIRE COULD NOT BE INSERTED THROUGH THE DESIGNATED CHANNEL. THE PROCEDURE COULD NOT BE INITIATED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084733 ↗
• MalfunctionMay 4, 2026Failure to Conduct; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 44 WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING A TRANSDUODENOSCOPIC LITHOTOMY PROCEDURE TO TREAT BILE DUCT STONE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE DEVICE COULD NOT CUT. 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: 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 25074996 ↗

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