Jagtome™ Pro RX 44 M00584440Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191506039288), received between Oct 18, 2024 and May 8, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME PRO RX 44 WAS ATTEMPTED TO BE USED DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE CANNULATION PERIOD OF THE PROCEDURE, IT WAS REPORTED THAT THE CUT WIRE DETACHED FROM THE TOME WHILE THE NURSE WAS BOWING THE DEVICE. 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 25126307 ↗
• MalfunctionOct 18, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME PRO RX 44 WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DEVICE WAS INTRODUCED INTO THE DUODENOSCOPE. ONCE IN POSITION WITHIN THE DUODENUM, THE TECHNICIAN ATTEMPTED TO BOW THE TOME AND THE CUTTING WIRE BROKE. IT WAS QUICKLY REMOVED FROM THE SCOPE. 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. NOTE: PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWED THE CUTTING WIRE WAS BROKEN AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20482732 ↗