Hydratome™ Pro RX 44 M00584420Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00191506039264), received between Aug 28, 2025 and Feb 24, 2026 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME PRO RX 44 WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUT WIRE BROKE DURING SPHINCTEROTOMY. 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 DUE TO 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 24434141 ↗
• MalfunctionDec 30, 2025Leak/Splash; Deformation Due to Compressive Stress; Leak/Splash; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME PRO RX 44 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE TOME WAS LEAKING. A VIDEO CLIP OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE TIP OF THE WORKING LENGTH WAS LEAKING. ADDITIONALLY, THE CUTTING WIRE APPEARED TO BE KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. 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 HAVE FULLY RECOVERED. ADDITIONAL INFORMATION RECEIVED ON JANUARY 12, 2026. IT WAS REPORTED THAT THE EVENT DATE OR PROCEDURE DATE OCCURRED ON (B)(6) 2025. IT WAS REPORTED THAT THE ANATOMY LOCATION OF THE PROCEDURE WAS AT THE COMMON BILE DUCT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME PRO RX 44 DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23930713 ↗
• MalfunctionAug 28, 2025Break; Failure to Conduct; Break; Failure to Conduct

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME PRO RX 44 WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, ACCESS WAS MADE TO BILE DUCT. AS THEY TRIED TO CUT SPHINCTEROTOMY THE WIRE BROKE, AND POWER STOPPED DELIVERY/CUT MODE. 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 22914333 ↗