Jagtome RX 44Recalls & reported problems across all models

We found 4 models of Jagtome RX 44 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 Feb 20, 2018 and Jun 29, 2026 — classified as 2 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Break” (61 reports).

4 FDA recall records name at least one of these models by its device identifier, 4 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

Jagtome 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. Dec 22, 2021Open, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0776-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

2. Dec 22, 2021Open, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0775-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

3. Dec 22, 2021Open, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0774-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

4. Dec 22, 2021Open, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0773-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported Jagtome RX 44 problems

Jagtome RX 44 models

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

• Jagtome RX 44 M00573040

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall40 reports
• Jagtome RX 44 M00573060

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall22 reports
• Jagtome RX 44 M00573050

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall13 reports
• Jagtome RX 44 M00573070

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall0 reports

Recent Jagtome RX 44 adverse event reports

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

• MalfunctionJun 29, 2026Break; Use of Device Problem; Material Twisted/Bent

  It was reported to Boston Scientific Corporation that a Jagtome RX 44 was attempted to be used in the common duct during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure to treat stones in the common duct performed on (b)(6) 2026.During the procedure. the cutting wire came out of the packaging twisted, and when turned the sphincterotome to perform sphincterotomy, the cutting wire snapped. It was reported that no part of the cutting wire was detached and fell into the patient. A second Jagtome RX 44 was attempted to be used; however, the cutting wire was completely twisted. They did not introduce it in the patient and discarded it immediately. The procedure was completed with a third Jagtome RX 44. There were no patient complications as a result of this event and the patient's condition was reported to be fully recovered.Note: It was reported that the cutting wire came out of the packaging twisted; however, per the Instructions for Use (IFU), Precaution: Kinks in the catheter will hinder injection capability. Do not use the Sphincterotome if any defect is found during inspection.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25661255 ↗
• MalfunctionApr 30, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE CUTTING WIRE BROKE. A PHOTO WAS PROVIDED FROM THE CUSTOMER SHOWING THAT THE CUTTING WIRE WAS INTACT AND THE WIRE ANCHOR WAS DISLODGED. 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 25038800 ↗
• MalfunctionApr 24, 2026Failure to Fold

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS ATTEMPTED TO BE USED IN THE PAPILLA, COMMON BILE DUCT AND DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE DID NOT BOW, SO THEY COULD NOT DO THE CUT OF THE SPHINCTER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: THE WIRE DETACHED/SEPARATED PLEASE REFER TO BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24976481 ↗
• MalfunctionMar 17, 2026Failure to Fold; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT GALLSTONE WITH CHOLECYSTITIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CUTTING WIRE COULD NOT BE PULLED UP. 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 RESULTS: THE CUTTING WIRE KINKED. PLEASE REFER TO BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619678 ↗
• MalfunctionFeb 9, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2026. DURING PROCEDURE, A JAGTOME RX 44 WAS USED TO CUT THE AMPULLA OF THE PATIENT. WHILE PERFORMING THE SPHINCTEROTOMY, THE CUTTING WIRE SNAPPED. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY. 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 24292892 ↗
• MalfunctionJul 18, 2025Difficult to Advance; Material Deformation; Material Twisted/Bent; Difficult to Advance; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT AN ULCER OF DESCENDING DUODENAL BULB PERFORMED ON (B)(6), 2025. DURING THE PREPARATION, THE TIP OF THE JAGTOME RX 44 WAS TWISTED AND THE GUIDEWIRE COULD NOT EXIT NORMALLY. 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: 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 22543442 ↗
• MalfunctionMay 23, 2025Break; Break

  NOTE: THIS REPORT PERTAINS TO ONE TRUETOME JAG 44 AND ONE JAGTOME RX 44 USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED DURING A SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE WAS CUT DURING SPHINCTEROTOMY. THE SAME PROBLEM OCCURRED WITH THE TRUETOME JAG 44. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081900 ↗
• MalfunctionMay 13, 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 A JAGTOME RX 44 WAS USED IN THE DUODENUM IN FRONT OF THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE OF THE JAGTOME RX 44 BROKE DURING CUTTING. 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 22015387 ↗
• MalfunctionApr 11, 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 A JAGTOME RX 44 WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2025. DURING THE PROCEDURE, THE CUTTING WIRE OF THE JAGTOME RX 44 BROKE WHEN THE DEVICE WAS BOWED FOR THE FIRST TIME. 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 21829743 ↗
• MalfunctionMar 25, 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 A JAGTOME RX 44 WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE OF THE JAGTOME RX 44 BROKE AFTER ENERGIZING THE THIRD TIME. THE DEVICE WAS APPROXIMATELY TENSED FOR ABOUT ONE THIRD. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691953 ↗
• MalfunctionMar 24, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS BEING PREPARED FOR USE IN THE COMMON BILE DUCT (CBD) DURING A CHOLEDOCHOLITHIASIS WITH CHOLANGITIS PROCEDURE TO BE PERFORMED ON (B)(6) 2025. DURING PREPARATION, THE CUTTING WIRE WAS FRACTURED WHEN THE PACKAGE WAS OPENED. A PHOTO OF THE DEVICE WAS PROVIDED BY THE COMPLAINANT AND SHOWED THAT THE CUTTING WIRE WAS BROKEN AND KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGTOME RX 44. 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 21683110 ↗
• MalfunctionJan 13, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN IN POSITION TO PERFORM SPHINCTEROTOMY, CUTTING WAS NOT WORKING. AFTER TROUBLESHOOTING, IT WAS DISCOVERED THAT THE CUT WIRE OF THE TOME BROKE AT THE PROXIMAL END. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGTOME RX 44. 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 21138921 ↗
• MalfunctionDec 27, 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 A JAGTOME RX 44 WAS USED IN THE PAPILLA VATERI DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN STARTED TO CUT THE PAPILLA, AND THE CUTTING WIRE BROKE IMMEDIATELY. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGTOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029079 ↗
• MalfunctionSep 9, 2024Break; Device Slipped; Adverse Event Without Identified Device or Use Problem; Break; Device Slipped; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6)2024. DURING PREPARATION, THE DEVICE WAS UNPACKED, AND IT WAS NOTICED THAT THE GUIDEWIRE WAS IN THE MIDDLE OF THE TOME, AND OUT OF THE GUIDEWIRE CHANNEL. THE GUIDEWIRE WAS PUT BACK INTO THE CHANNEL AND THE TOME WORKED AS INTENDED BUT IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE DEVICE WAS RETURNED, AND A DEVICE ANALYSIS REVEALED THE CUTTING WIRE OF THE DEVICE WAS BLACKENED, KINKED AND BROKEN FROM THE PROXIMAL PIERCE HOLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDINGS OF CUTTING WIRE BREAK. PLEASE SEE DEVICE ANALYSIS RESULTS FOR FULL INVESTIGATION DETAILS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: THE CUTTING WIRE BROKEN. PLEASE REFER TO BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169692 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 44 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN ENTERED THE PAPILLA WITH THE DEVICE, THE NURSE BOWED THE DEVICE AND THE PHYSICIAN ADDED ENERGY FROM THE GENERATOR. IT WAS REPORTED THAT BLEEDING WAS IMMEDIATE AFTER SPHINCTEROTOMY, RESULTING IN HEAVY BLEEDING AND HEMATOMA. THE PROCEDURE WAS ABLE TO BE COMPLETED USING THE ORIGINAL JAGTOME RX 44 DEVICE. THE PATIENT HAD HEAVY BLEEDING AND HEMATOMA. A METAL STENT WAS PLACED TO STOP THE BLEEDING AND THE PATIENT WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19912242 ↗

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