Hydratome RX 49 M00583010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729755166), received between Jun 5, 2019 and Jul 17, 2019 — classified as 1 injury, 1 malfunction.

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-0764-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

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.

• InjuryJul 17, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 49 WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE CUTTING WIRE OF THE HYDRATOME RX 49 BROKE OFF. REPORTEDLY, AN EXTRACTOR PRO DEVICE WAS USED TO CLEAN THE BILE DUCT AND RETRIEVE THE BROKEN PIECE; HOWEVER, THEY WERE NOT ABLE TO FIND THE DETACHED PIECE. THE PROCEDURE WAS COMPLETED WITH THE EXTRACTOR PRO. IN THE PHYSICIAN'S ASSESSMENT, THE CUTTING WIRE PASSED THOUGH THE MAIN BILE DUCT. A SYSTEMATIC SCANNER WAS SCHEDULED TO TAKE PLACE A MONTH FOLLOWING THE PROCEDURE. 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 OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8799009 ↗
• MalfunctionJun 5, 2019Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 49 WAS USED DURING A SPHINCTEROTOMY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE CUTTING WIRE BROKE DURING SPHINCTEROTOMY. ADDITIONALLY, A PHOTO OF THE DEVICE WAS PROVIDED WHICH SHOWED THAT THE CUTTING WIRE WAS ALSO KINKED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8670110 ↗