ENDOGATORRecalls & reported problems across all models
Medivators Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 6 models of ENDOGATOR by Medivators Inc. in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Nov 22, 2016 and Sep 10, 2026 — classified as 1 injury, 24 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (19 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ENDOGATOR problems
Device problems
- Leak/Splash19
- No Flow3
- Fluid/Blood Leak2
- Backflow1
- Break1
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Exposure to Body Fluids1
- No Known Impact Or Consequence To Patient1
ENDOGATOR models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ENDOGATOR 100130Endoscopic Irrigation/Suction System13 reports
- ENDOGATOR 4005644endoscopic irrigation/suction system5 reports
- ENDOGATOR 100241Endoscopic Irrigation/Suction System4 reports
- ENDOGATOR 100242Endoscopic Irrigation/Suction System2 reports
- ENDOGATOR 100126Endoscopic Irrigation/Suction System1 report
- ENDOGATOR 200230Endoscopic Irrigation/Suction System1 report
Recent ENDOGATOR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Leak/Splash
The user facility reported that water was leaking from their Endogator Tubing during a patient procedure. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718491 ↗InjuryAug 27, 2026Crack
The user facility reported that during a patient procedure the ENDOGATOR Auxiliary Water Jet Connector ¿cracked¿ subsequently causing water to leak onto the floor. Another device was utilized and the procedure was completed successfully following a short delay. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50479600 ↗MalfunctionMay 27, 2026Leak/Splash
THE USER FACILITY REPORTED THAT WHEN INSERTING THE ENDOGATOR TUBING SET INTO THEIR STERIS GI 4000 MACHINE, THE TUBING IS SPLITTING, ALLOWING WATER TO LEAK ONTO THE FLOOR. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25306694 ↗MalfunctionMar 26, 2026Leak/Splash
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR ENDOGATOR TUBING WAS LEAKING WATER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY USING A DIFFERENT TUBING. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699033 ↗MalfunctionOct 15, 2025No Flow; No Flow
THE USER FACILITY REPORTED VIA MW5174602 THAT "ENDOGATOR IRRIGATION TUBING HOOKED UP TO ENDOSCOPE AND NO WATER WOULD COME THROUGH. THIS WAS DISCOVERED PRIOR TO PATIENT INVOLVEMENT - NO PATIENT HARM." NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23302706 ↗MalfunctionOct 15, 2025No Flow; No Flow
THE USER FACILITY REPORTED VIA MW5174645 THAT "ENDOGATOR IRRIGATION TUBING HOOKED UP TO ENDOSCOPE AND NO WATER WOULD COME THROUGH. THIS WAS DISCOVERED PRIOR TO PATIENT INVOLVEMENT - NO PATIENT HARM." NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23302650 ↗MalfunctionOct 15, 2025No Flow; No Flow
THE USER FACILITY REPORTED VIA MW5174603 THAT "ENDOGATOR IRRIGATION TUBING HOOKED UP TO ENDOSCOPE AND NO WATER WOULD COME THROUGH. THIS WAS DISCOVERED PRIOR TO PATIENT INVOLVEMENT - NO PATIENT HARM." NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23302462 ↗MalfunctionJan 3, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR ENDOGATOR IRRIGATION TUBING WAS LEAKING WATER AT THE CONNECTION TO THE CO2 PUMP ONTO THE FLOOR. USER FACILITY PERSONNEL CHANGED THE TUBING RESULTING IN A SHORT PROCEDURE DELAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21071855 ↗MalfunctionApr 1, 2024Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED VIA VIGILANCE REPORT TO ANSM THAT THEY HAD LEAKS WITH THEIR ENDOGATOR AUXILIARY WATER JET CONNECTOR. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19015346 ↗MalfunctionMar 15, 2024Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT WATER LEAKED FROM THE PLUGS WHILE USING THEIR AUXILIARY WATER JET CONNECTOR. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18914258 ↗MalfunctionFeb 23, 2024Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THEIR ENDOGATOR AUXILIARY WATER JET CONNECTOR WAS CAUSING WATER TO FLOW OUT OF THE SCOPE WHILE THE AIR WAS TURNED ON. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18773839 ↗MalfunctionDec 14, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THEIR ENDOGATOR IRRIGATION TUBING WAS CRACKED AND LEAKING. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18326415 ↗MalfunctionDec 14, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THEIR ENDOGATOR IRRIGATION TUBING WAS CRACKED AND LEAKING. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18326361 ↗MalfunctionDec 14, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THEIR ENDOGATOR IRRIGATION TUBING WAS CRACKED AND LEAKING. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18326252 ↗MalfunctionDec 14, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THEIR ENDOGATOR IRRIGATION TUBING WAS CRACKED AND LEAKING DURING A PROCEDURE. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18326009 ↗
Other Medivators Inc. products
- Medivators Hookup99 models · 1 reports · 5 recalls
- Rapicide PA High-Level Disinfectant3 models · 80 reports
- Renaflo II Hemofilter2 models · 50 reports
- ENDO SMARTCAP5 models · 30 reports
- DEFENDO Air/Water/Suction and Biopsy Valve3 models · 22 reports
- ENDOGATOR hybrid irrigation tubing5 models · 20 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
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