Hydra SIT-577Recalls & reported problems
Boston Scientific Corporation · Irrigation Tubing System · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840253108449), received between Dec 20, 2019 and Dec 20, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Reflux within Device” (2 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
Device problems
- Reflux within Device2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 20, 2019Reflux within Device; Reflux within Device
NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT HYDRA IRRIGATION TUBING AND A WATER JET CONNECTOR WAS USED IN A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2019. ACCORDING TO THE COMPLAINANT, WHILE HYDRA IRRIGATION TUBING WAS CONNECTED TO A HYDRA WATER JET CONNECTOR, BACKFLOW OF LIQUID WAS OBSERVED. THE PROCEDURE WAS COMPLETED USING ANOTHER HYDRA IRRIGATION TUBING AND WATER JET CONNECTOR. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT WAS REPORTED TO BE STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9506180 ↗MalfunctionDec 20, 2019Reflux within Device; Reflux within Device
NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT HYDRA IRRIGATION TUBING AND A WATER JET CONNECTOR WAS USED IN A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, WHILE HYDRA IRRIGATION TUBING WAS CONNECTED TO A HYDRA WATER JET CONNECTOR, BACKFLOW OF LIQUID WAS OBSERVED. THE PROCEDURE WAS COMPLETED USING ANOTHER HYDRA IRRIGATION TUBING AND WATER JET CONNECTOR. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT WAS REPORTED TO BE STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9506177 ↗
Other PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE devices
- OLYMPUS OFP-2 (ROW)Keymed (Medical & Industrial Equipment) Limited · Pump, Air, Non-Manual, For Endoscope296 reports
- Olympus MAJ-1651Keymed (Medical & Industrial Equipment) Limited · Pump, Air, Non-Manual, For Endoscope125 reports
- Olympus WB991046OLYMPUS Winter & Ibe GmbH · Pump, Air, Non-Manual, For Endoscope81 reports
- ERBEFLO CleverCap® 20325-239Erbe Medical, LLC · Pump, Air, Non-Manual, For Endoscope1 recall24 reports
- OLYMPUS OFP-2 (US)Keymed (Medical & Industrial Equipment) Limited · Pump, Air, Non-Manual, For Endoscope1 recall22 reports
- ERBEFLO CleverCap® 20325-206Erbe Medical, LLC · Pump, Air, Non-Manual, For Endoscope1 recall5 reports
- ERBEFLO CleverCap® 20325-240Erbe Medical, LLC · Pump, Air, Non-Manual, For Endoscope1 recall3 reports
- ERBEFLO CleverCap® 20325-248Erbe Medical, LLC · Pump, Air, Non-Manual, For Endoscope1 recall3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page