ENDOGATOR hybrid irrigation tubing 100608Recalls & reported problems
Medivators Inc. · Class 2
All models of ENDOGATOR hybrid irrigation tubing (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00677964060861), received between Dec 13, 2023 and Mar 8, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 8, 2024Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THE TUBING CONNECTOR TO THEIR ENDOGATOR HYBRID TUBING DISCONNECTED SUBSEQUENTLY CAUSING WATER TO LEAK. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18867928 ↗MalfunctionDec 13, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT WATER LEAKS INTO THE AIR TUBING WHILE USING THEIR ENDOGATOR HYBRID IRRIGATION TUBING. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18319458 ↗MalfunctionDec 13, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT WATER LEAKS INTO THE AIR TUBING WHILE USING THEIR ENDOGATOR HYBRID IRRIGATION TUBING. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18319239 ↗MalfunctionDec 13, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT WATER LEAKS INTO THE AIR TUBING WHILE USING THEIR ENDOGATOR HYBRID IRRIGATION TUBING. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18318968 ↗MalfunctionDec 13, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT WATER LEAKS INTO THE AIR TUBING WHILE USING THEIR ENDOGATOR HYBRID IRRIGATION TUBING. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18317533 ↗
Other Endoscopic Irrigation/Suction System devices
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- andorate® A/W Channel Cleaning Adapter + 4-piece Valve Kit GAR3846GA Health Company Limited · Endoscopic Irrigation/Suction System1 recall0 reports
- BullDog® 1203-71Diversatek Healthcare, Inc. · Endoscopic Irrigation/Suction System1 recall0 reports
- ERBEFLO CleverCap® 20325-201Erbe Medical, LLC · Endoscopic Irrigation/Suction System1 recall0 reports
- 2-piece valve kit (Suction and Air/Water Valve) EN10229.2GA Health Company Limited · Endoscopic Irrigation/Suction System1 recall0 reports
- 4-piece valve kit(Suction, Air/Water, Biopsy Valves & Auxiliary Water Connector) EN10229.1GA Health Company Limited · Endoscopic Irrigation/Suction System1 recall0 reports
- ERBEFLO CleverCap® 20325-203Erbe Medical, LLC · Endoscopic Irrigation/Suction System1 recall0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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