Hydratome RX 44Recalls & reported problems across all models

We found 4 models of Hydratome RX 44 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 143 adverse event reports in the FDA's MAUDE database, received between Aug 7, 2017 and Mar 5, 2026 — classified as 6 injuries, 137 malfunctions.

The most frequently reported specific device problem is “Break” (105 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

Hydratome 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, 2021Class IIOpen, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0762-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

2. Dec 22, 2021Class IIOpen, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0761-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

3. Dec 22, 2021Class IIOpen, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0760-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

4. Dec 22, 2021Class IIOpen, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0759-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported Hydratome RX 44 problems

Hydratome RX 44 models

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

• Hydratome RX 44 M00583040

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall98 reports
• Hydratome RX 44 M00583050

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall39 reports
• Hydratome RX 44 M00583060

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall3 reports
• Hydratome RX 44 M00583070

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall3 reports

Recent Hydratome RX 44 adverse event reports

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

• MalfunctionMar 5, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT HYDRATOME RX 44 WAS ATTEMPTED TO BE USED IN THE AMPULLA OF DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THE SPHINCTEROTOME WAS BOWED AND THE PAPILLOTOMY WAS WIDENED, THE CUTTING WIRE SNAPPED. IT WAS REPORTED THAT NO PART OF THE DEVICE WAS DETACHED AND FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS 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 24527092 ↗
• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN HYDRATOME RX 44 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE TOME WIRE WAS BROKEN DURING SPHINCTEROTOMY. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME 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 23544751 ↗
• MalfunctionNov 6, 2025Break; Deformation Due to Compressive Stress; Material Deformation; Break; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN HYDRATOME RX WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CHOLEDOCHOLITHIASIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE WAS BROKEN UPON BOWING OF THE TOME IN PREPARING FOR SPHINCTEROTOMY. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. A PHOTO WAS PROVIDED OF THE DEVICE OUTSIDE THE PATIENT AND SHOWS THE CUTTING WIRE WAS BROKEN AND KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME RX. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493852 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED IN THE HEPATOPANCREATIC BILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON MAY/JUNE. THE SPECIFIC DATE IS UNKNOWN. AFTER THE PROCEDURE, PATIENT COMING BACK IN WITH DELAYED BLEEDING FROM THE SPHINCTEROTOMY DUE TO THE INCORRECT ERBE SETTINGS. THE BLEEDING WAS TREATED WITH ENDOSCOPIC HEMOSTASIS. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE AT THE TIME OF EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23327672 ↗
• MalfunctionAug 7, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS INSPECTED UPON RECEIVING ON JULY 16, 2025. DURING THE INSPECTION OF THE DEVICE, IT WAS NOTED THAT MOISTURE WAS PRESENT INSIDE THE STERILE PACKAGE. THERE WERE NO PATIENT AND PROCEDURE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739854 ↗
• MalfunctionJul 15, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS RECEIVED BY THE CUSTOMER ON AN UNKNOWN DATE. IT WAS REPORTED THAT THERE ARE HOLES IN THE PACKAGING. A PHOTO OF THE STERILE POUCH OF THE DEVICE WAS PROVIDED AND SHOWED THAT THE STERILE POUCH WAS TORN. THE PRODUCT WAS NOT USED IN A PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22503777 ↗
• MalfunctionJul 14, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS RECEIVED BY THE CUSTOMER ON AN UNKNOWN DATE. IT WAS REPORTED THAT THERE ARE HOLES IN THE PACKAGING. A PHOTO OF THE STERILE POUCH OF THE DEVICE WAS PROVIDED AND SHOWED THAT THE STERILE POUCH WAS TORN. THE PRODUCT WAS NOT USED IN A PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22503776 ↗
• MalfunctionJun 24, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT A STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER GAINING ACCESS TO THE COMMON BILE DUCT (CBD), SPHINCTEROTOMY WAS ATTEMPTED. THE DEVICE WAS BOWED DURING CUTTING AND THE CUT WIRE OF THE HYDRATOME RX 44 BROKE. 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 22323527 ↗
• 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 HYDRATOME RX 44 WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT A STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NURSE WAS BENDING THE CUTTING WIRE AS THE PHYSICIAN WAS PERFORMING SPHINCTEROTOMY. THE DEVICE WAS ENERGIZED AND THE CUTTING WIRE OF THE HYDRATOME RX 44 BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 22165416 ↗
• MalfunctionJun 3, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE WAS INTACT, BUT THE WIRE ANCHOR DISLODGED FROM THE CATHETER. A PHOTO OF THE DEVICE OUTSIDE THE PATIENT WAS PROVIDED AND SHOWED THAT THE CUTTING WIRE WAS INTACT, BUT THE WIRE ANCHOR WAS DISLODGED FROM THE CATHETER. THE DEVICE WAS REMOVED, AND 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 22137606 ↗
• MalfunctionMay 14, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN WENT TO PERFORM SPHINCTEROTOMY AND WHEN STEPPING ON THE PEDAL THE CUTTING WIRE BROKE WHERE IT CONNECTS TO THE PROXIMAL PART OF THE TOME. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22016761 ↗
• MalfunctionMar 19, 2025Break; Failure to Fold; Adverse Event Without Identified Device or Use Problem; Break; Failure to Fold; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO TENSION THE DEVICE, THE CUTTING WIRE BROKE FROM THE BEGINNING OF USE. 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 21649280 ↗
• MalfunctionMar 5, 2025Break; Failure to Conduct; Adverse Event Without Identified Device or Use Problem; Break; Failure to Conduct; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, THE DEVICE SPARKED AND THE CUTTING WIRE OF THE HYDRATOME RX 44 BROKE. 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 21528662 ↗
• MalfunctionNov 14, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS BEING PREPARED FOR USE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO BE PERFORMED ON AN UNKNOWN DATE. DURING PREPARATION, UPON OPENING THE PACKAGE IT WAS OBSERVED THAT THE CUTTING WIRE WAS BROKEN OFF THE TOME. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685582 ↗
• MalfunctionOct 16, 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 HYDRATOME RX 44 WAS USED IN THE BILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE HYDRATOME 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 HYDRATOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20463499 ↗

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