Ultratome XLRecalls & reported problems across all models

We found 3 models of Ultratome XL by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 328 adverse event reports in the FDA's MAUDE database, received between Nov 8, 2017 and Sep 30, 2026 — classified as 3 injuries, 325 malfunctions.

The most frequently reported specific device problem is “Break” (241 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 Ultratome XL problems

Ultratome XL models

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

• Ultratome XL M00535900

  SNARE, FLEXIBLE
  205 reports
• Ultratome XL M00535920

  SNARE, FLEXIBLE
  122 reports
• Ultratome XL M00535930

  SNARE, FLEXIBLE
  1 report

Recent Ultratome XL 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953998 ↗
• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951035 ↗
• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951030 ↗
• MalfunctionSep 24, 2026Break

  It was reported to Boston Scientific Corporation that an Ultratome XL was attempted to be used in the duodenal papilla during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure to treat Lithiasis performed on (b)(6) 2026.During the procedure, the cutting wire was fractured after being energized. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event. The patient condition following procedure was reported to be stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877093 ↗
• MalfunctionSep 18, 2026Failure to Align; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50822196 ↗
• MalfunctionAug 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50308219 ↗
• MalfunctionAug 7, 2026Break; Failure to Conduct; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  It was reported to Boston Scientific Corporation that an Ultratome XL was used in the ampulla during an Endoscopic Retrograde Cholangiopancreatography (ERCP) to treat biliary stones performed on (b)(6) 2025.During the procedure, the device stopped passing current. The connections were checked and patient plate was readjusted but no energy got transferred. The procedure was completed with another of the same device.There were no reported patient complications as a result of this event.Note:This event has been deemed a reportable event based on the investigation finding of wire break and wire kinked. Please see Block H11 for full investigation details.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50180112 ↗
• MalfunctionJul 9, 2026Deformation Due to Compressive Stress; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25774275 ↗
• MalfunctionJul 6, 2026Break; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE TO PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE TIP WIRE AT THE FRONT OF THE KNIFE BROKE. 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. NOTE: IT WAS REPORTED THAT THE DEVICE WAS ENERGIZED WHEN NOT IN CONTACT WITH TISSUE. PER THE INSTRUCTIONS FOR USE (IFU), PRECAUTION: IT IS RECOMMENDED TO MAINTAIN DIRECT AND CONSTANT CONTACT WITH TISSUE WHEN APPLYING ELECTROCAUTERY CURRENT. FAILURE TO DO SO MAY RESULT IN BROKEN CUT WIRE, DAMAGE TO THE ENDOSCOPE AND/OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25721926 ↗
• MalfunctionJun 6, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT GALLSTONES PERFORMED ON (B)(6) 2026. 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 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 25419845 ↗
• MalfunctionMay 27, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CUTTING WIRE BROKE DURING THE INITIAL PAPILLA PRE-CUT, DESPITE THE ELECTROSURGICAL UNIT BEING SET TO THE MINIMUM LEVEL. 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 25303128 ↗
• MalfunctionApr 29, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE WIRE ANCHOR WAS DISLODGED FROM THE CATHETER DURING DISSECTION OF THE COMMON BILE DUCT 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 AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25038137 ↗
• MalfunctionApr 24, 2026Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE DUODENAL PAPILLARY SPHINCTER DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE TO TREAT COMMON BILE DUCT STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PATIENT UNDERWENT RESECTION OF A LESION AT THE DUODENAL PAPILLA. WHILE PERFORMING THE INCISION OF THE DUODENAL PAPILLARY SPHINCTER, THE CUTTING WIRE AT THE TIP OF THE DEVICE SUDDENLY BROKE, MAKING IT IMPOSSIBLE TO CONTINUE THE INCISION. THE PROCEDURE WAS PAUSED FOR 20 MINUTES TO ALLOW FOR DEVICE EXCHANGE, AFTER WHICH IT RESUMED. 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: IT WAS REPORTED THAT THE DEVICE WAS ENERGIZED PRIOR TO BOWING AND THE DEVICE WAS ENERGIZED WHEN NOT IN CONTACT WITH TISSUE. "PER 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24976046 ↗
• MalfunctionApr 23, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24973709 ↗
• MalfunctionApr 21, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS UNPACKED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT INTESTINAL OBSTRUCTION PERFORMED ON (B)(6) 2026. DURING UNPACKING, IT WAS NOTICED THAT THE CUTTING WIRE EXTENDED OUT. A PHOTO WAS PROVIDED FROM THE CUSTOMER SHOWING THAT THE CUTTING WIRE WAS 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 24942571 ↗

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