Hydra SIT-575Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840253108418), received between Jul 11, 2024 and Jan 2, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Reflux within Device” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2025Reflux within Device; Use of Device Problem; Reflux within Device; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT HYDRA IRRIGATION TUBING WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED FOR SCREENING ON (B)(6) 2024. DURING THE PROCEDURE, THERE WAS BACKFLOW INTO THE IRRIGATION TUBE, THE COLOR OF THE FLUID WAS CAUSED BY BLOOD. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21056109 ↗
• MalfunctionNov 19, 2024Reflux within Device; Use of Device Problem; Reflux within Device; Use of Device Problem

  IT WAS REPORTED, TO BOSTON SCIENTIFIC CORPORATION. THAT HYDRA IRRIGATION TUBING WAS USED IN THE COLON, DURING A COLONOSCOPY PROCEDURE. PERFORMED FOR SCREENING ON (B)(6) 2024. DURING THE PROCEDURE, BACKFLOW OF BLOOD COLORED FLUID INTO THE IRRIGATION TUBE WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED, THAT THE CUSTOMER CONNECTED THE ENDOWASHER DIRECTLY TO THE LUER CONNECTOR OF THE IRRIGATION CHANNEL OF THE ENDOSCOPE. HOWEVER, THE HYDRA INSTRUCTIONS FOR USE (IFU) STATE, TO CONNECT THE IRRIGATION TUBING, THE APPROPRIATE IRRIGATION SCOPE CONNECTOR THAT IS ATTACHED TO THE AUXILIARY WATER JET PORT. THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20722572 ↗
• MalfunctionSep 30, 2024Reflux within Device; Reflux within Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT HYDRA IRRIGATION TUBING WAS USED IN A CHOLANGIOSCOPY PROCEDURE PERFORMED IN COMMON BILE DUCT. DURING THE PROCEDURE, THE VALVE THAT WAS NOT WORKING. THE FLUSHING FLUID RAN BACK INTO THE SYSTEM. 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 20334804 ↗
• MalfunctionSep 23, 2024Reflux within Device; Reflux within Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT HYDRA IRRIGATION TUBING WAS USED IN A CHOLANGIOSCOPY PROCEDURE PERFORMED IN COMMON BILE DUCT ON AN UNKNOWN PROCEDURE DATE. DURING THE PROCEDURE, THE ONE-WAY CHECK VALVE DID NOT FUNCTION PROPERLY. THE FLUSHING FLUID RAN BACK INTO THE SYSTEM. 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 20281198 ↗
• MalfunctionJul 11, 2024Reflux within Device; Reflux within Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT HYDRA IRRIGATION TUBING WAS USED IN AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE WATER FLEW BACK DURING IRRIGATION. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19719263 ↗