TRUEtome Jag 44Recalls & reported problems across all models

We found 4 models of TRUEtome Jag 44 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 80 adverse event reports in the FDA's MAUDE database, received between Oct 20, 2017 and Sep 10, 2026 — classified as 80 malfunctions.

The most frequently reported specific device problem is “Break” (66 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 TRUEtome Jag 44 problems

TRUEtome Jag 44 models

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

• TRUEtome Jag 44 M00583100

  Unit, electrosurgical, endoscopic (with or without accessories)
  53 reports
• TRUEtome Jag 44 M00583140

  Unit, electrosurgical, endoscopic (with or without accessories)
  24 reports
• TRUEtome Jag 44 M00583090

  Unit, electrosurgical, endoscopic (with or without accessories)
  2 reports
• TRUEtome Jag 44 M00583110

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 report

Recent TRUEtome Jag 44 adverse event reports

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

• MalfunctionSep 10, 2026Break; Deformation Due to Compressive Stress; Material Integrity Problem

  It was reported to Boston Scientific Corporation that a TRUEtome Jag 44 was being prepared for used in the Duodenal papilla during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure to treat Common bile duct stone to be performed on (b)(6)2026.During preparation, when the package was unpacked, it was found that the tip of the tome was split. Additionally, 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 was 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 50721272 ↗
• MalfunctionSep 9, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699121 ↗
• MalfunctionJul 31, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50094833 ↗
• MalfunctionJul 21, 2026Break; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25894139 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CHOLANGITIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT UPON THE INCISION THE SPHINCTEROTOME CUTTING WIRE SUDDENLY RUPTURED. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706583 ↗
• MalfunctionFeb 23, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE TRUETOME WAS PUSHED INTO THE AMPULLA AND UPON PULLING IT OUT THE CUT WIRE CAME OFF FROM THE TRUETOME. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. A VIDEO WAS PROVIDED BY THE CUSTOMER AND SHOWED THAT THE WIRE ANCHOR WAS DISLODGED. 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 WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24423813 ↗
• MalfunctionFeb 11, 2026Break; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CBD STONES PERFORMED ON (B)(6) 2026. AFTER UNPACKING, IT WAS FOUND THAT THE CUTTING HEAD DEVIATED FROM THE CUTTING WIRE, AND THE INNER CORE OF THE HANDLE WAS FRACTURED. 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 24317094 ↗
• MalfunctionDec 8, 2025Deformation Due to Compressive Stress; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS USED IN THE PORTA HEPATIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PREPARATION OUTSIDE THE PATIENT, IT WAS REPORTED THAT THE TIP OF THE TOME AND THE CUTTING WIRE WERE OFFSET, AND THE ATTEMPT TO INTUBATE WAS UNSUCCESSFUL. THE TIP OF THE TOME WAS NOT IN THE CORRECT POSITION WITH THE CUTTING WIRE; IT WAS IN A COILED SHAPE AND UNABLE TO BE ROTATED. 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 CUTTING WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23752500 ↗
• MalfunctionNov 24, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CHOLELITHOTOMY PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT AFTER UNPACKING, IT WAS FOUND THAT THE TIP OF THE CUTTING WIRE WAS SLIGHTLY TO THE RIGHT. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF CUTTING WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23640454 ↗
• MalfunctionOct 6, 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 TRUETOME JAG 44 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, WHEN THE ELECTROTOMY WAS PERFORMED AFTER THE POWER SUPPLY WAS CONNECTED, THE CUTTING WIRE OF THE TOME WAS FRACTURED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRUETOME JAG 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 23228359 ↗
• MalfunctionSep 26, 2025Break; Deformation Due to Compressive Stress; Material Deformation; Break; Deformation Due to Compressive Stress; Material Deformation

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A TRUETOME JAG 44 WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, INCISION OF THE PAPILLA WAS PERFORMED AND THE CUTTING WIRE ON THE PROXIMAL SIDE OF THE DEVICE BROKE. A SECOND TRUETOME JAG 44 WAS ATTEMPTED TO BE USED BUT, DURING INCISION OF THE PAPILLA, THE CUTTING WIRE ALSO BROKE ON THE PROXIMAL SIDE OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRES DETACHED AND FELL INTO THE PATIENT. PHOTOS OF THE COMPLAINT DEVICES OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND BOTH SHOWED THE CUTTING WIRE WAS BROKEN AND KINKED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23152023 ↗
• MalfunctionSep 25, 2025Break; Deformation Due to Compressive Stress; Material Deformation; Break; Deformation Due to Compressive Stress; Material Deformation

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A TRUETOME JAG 44 WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, INCISION OF THE PAPILLA WAS PERFORMED AND THE CUTTING WIRE ON THE PROXIMAL SIDE OF THE DEVICE BROKE. A SECOND TRUETOME JAG 44 WAS ATTEMPTED TO BE USED BUT, DURING INCISION OF THE PAPILLA, THE CUTTING WIRE ALSO BROKE ON THE PROXIMAL SIDE OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRES DETACHED AND FELL INTO THE PATIENT. PHOTOS OF THE COMPLAINT DEVICES OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND BOTH SHOWED THE CUTTING WIRE WAS BROKEN AND KINKED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23146254 ↗
• MalfunctionAug 28, 2025Failure to Fold; Material Deformation; Adverse Event Without Identified Device or Use Problem; Failure to Fold; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS PREPARED TO BE USE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PREPARATION OUTSIDE THE PATIENT, THE DEVICE WAS UNPACKED, AND IT WAS NOTED THAT THE BOW COULD NOT BE OPENED NORMALLY. AFTER FORCING THE BOW TO BE OPENED, THE PLASTIC END KINKED AT 90 DEGREES. 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: VIDEO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND SHOWS THE WORKING LENGTH KINKED. 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 22920065 ↗
• MalfunctionAug 28, 2025Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN TRUETOME JAG 44 WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE TIP OF THE TRUETOME WAS NOT MANIPULATED. HOWEVER, THE TIP OF THE DEVICE DEFLECTED NATURALLY AND COULD NOT BE IN PLACED BY ROTATING THE HANDLE. 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 22920056 ↗
• MalfunctionJun 9, 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 TRUETOME JAG 44 WAS ATTEMPTED TO BE USED IN THE BILIARY DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, 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 TRUETOME JAG 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165353 ↗

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