Hydra SIT-355Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816849016948), received between Oct 2, 2019 and Nov 28, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

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. How this data works · Data updated Oct 13, 2026.

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.

• MalfunctionNov 28, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRA IRRIGATION TUBING WAS USED DURING A COLONOSCOPY PROCEDURE ON NOVEMBER 01, 2023. PRIOR TO THE PROCEDURE, THEY FOUND BLACK HUMAN HAIR IN THE STERILE PACKAGING OF THE HYDRA IRRIGATION TUBING. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18215399 ↗
• MalfunctionOct 2, 2019Reflux within Device; Reflux within Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRA IRRIGATION TUBING WAS USED IN COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT A YELLOWISH FLUID HAD INFILTRATED THE HYDRA IRRIGATION TUBING. THE PROCEDURE WAS COMPLETED USING ANOTHER HYDRA IRRIGATION TUBING. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9147907 ↗