ENDOGATOR 4005644Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 40677964030985), received between Oct 15, 2025 and May 27, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “No Flow” (3 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. How this data works · Data updated Oct 13, 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.

• 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 ↗