Hydratome RX 44 M00583060Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729755210), received between Dec 20, 2018 and May 11, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier, 1 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, 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.

Recalls naming this device

1. 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 ↗

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.

• MalfunctionMay 11, 2022Break; Leak/Splash; Material Deformation; Break; Leak/Splash; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS INTENDED TO BE USED IN A PROCEDURE PERFORMED ON (B)(6) 2022. PRIOR TO THE PROCEDURE, IT WAS NOTICED THAT THE WIRE WAS BROKEN. ADDITIONALLY, THE WIRE WAS KINKED AND THERE WAS A LEAK FROM THE WORKING LENGTH OF THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. A PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWS THE WIRE WAS BROKEN AND KINKED, AND THERE WAS A LEAK FROM THE WORKING LENGTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14355126 ↗
• MalfunctionMay 26, 2021Leak/Splash; Appropriate Device Problem Term/Code Not Available; Leak/Splash; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED IN THE BILIARY SYSTEM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. AFTER INTRODUCING THE HYDRATOME RX 44 AND THE GUIDEWIRE WAS STRIPPED, IT WAS NOTICED THAT THERE WAS SEVERE AIR LEAK AS THE PHYSICIAN WAS NOT ABLE TO INSUFFLATE AIR INTO THE BOWEL IN ORDER TO VISUALIZE THE PAPILLA. GLUCAGON WAS USED TO DECREASE THE MOVEMENT OF THE SMALL BOWEL WITH NO SUCCESS. THE SCOPE WAS CHECKED FOR LEAKS AND ALL BUTTONS WERE EXCHANGED INCLUDING THE BIOPSY VALVE BEFORE IT WAS DECIDED TO CANCEL THE PROCEDURE AND RESCHEDULE FOR THE FOLLOWING DAY. ON (B)(6) 2021, A NEW SCOPE WAS USED AND TESTED FOR AIR LEAKS. AS SOON AS THE SECOND HYDRATOME RX 44 WAS INTRODUCED AND THE GUIDEWIRE WAS STRIPPED, THE SAME PROBLEM OCCURRED. THEY AGAIN EXCHANGED ALL BUTTONS INCLUDING THE BIOPSY VALVE. THE PHYSICIAN PLACED THE GUIDEWIRE BACK INTO THE HYDRATOME RX 44 AND COMPLETED THE PROCEDURE WITH A LONG WIRE SYSTEM. IN THE PHYSICIAN'S ASSESSMENT THE AIR LEAK WAS DUE TO THE HYDRATOME RX 44 DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11888548 ↗
• MalfunctionDec 20, 2018Break; 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 PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE CUTWIRE ON THE TOME BROKE WHEN THEY WERE BOWING TO CUT AND DO A SPHINCTEROTOMY. THERE WAS NO PART OF THE DEVICE DETACHED INSIDE THE PATIENT. THERE WERE NO INJURY NOR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8188217 ↗