DEFENDO Air/Water/Suction and Biopsy Valve 100305 (UDI 00677964060250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00677964060250), received between Nov 2, 2016 and Sep 11, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionSep 11, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THEIR DEFENDO BIOPSY VALVE WAS LEAKING RESULTING IN A SHORT PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT DEVICE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23030679 ↗
• MalfunctionJul 11, 2024Device Difficult to Setup or Prepare; Insufficient Device Problem Information; Device Difficult to Setup or Prepare; Insufficient Device Problem Information

  THE USER FACILITY REPORTED VIA VIGILANCE REPORT TO ANSM THAT THEY ARE EXPERIENCING "PROBLEMS WITH THE OPERATING CHANNEL VALVE (BLACK CAP): ON SEVERAL OCCASIONS THE SAMPLE GOT STUCK AT THE OPENING OF THIS CAP WITH THE SUCTION VALVE (DEVICE WITH A RED DOT): DID NOT RETURN TO ITS INITIAL POSITION AFTER ASPIRATION DURING THE EXAMINATION." NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19719770 ↗
• InjurySep 6, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED BY THE FACILITY THAT DURING AN UPPER GI ENDOSCOPY PROCEDURE A DEFENDO SINGLE USE SUCTION VALVE WAS REPORTED TO BE STUCK IN THE ENDOSCOPE. DUE TO THE LENGTH OF THE PROCEDURE, THE PATIENT WAS TAKEN TO THE MEDICAL INTENSIVE CARE UNIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8971027 ↗
• InjurySep 22, 2017Use of Device Problem; Use of Device Problem

  THE FACILITY REPORTED REPROCESSING AND REUSING A DISPOSABLE DEFENDO VALVE IN A PATIENT PROCEDURE. THE DEFENDO VALVE IS INTENDED FOR SINGLE USE AND THUS THERE IS POTENTIAL FOR PATIENT CROSS-CONTAMINATION.

  Patient problems: Exposure to Body Fluids

  MAUDE report 6886561 ↗
• MalfunctionNov 2, 2016Fluid/Blood Leak; Fluid/Blood Leak

  A FACILITY REPORTED THAT A DEFENDO DISPOSABLE AIR/WATER VALVE MALFUNCTIONED BY SPURTING IRRIGATION FLUID DURING THE PRIMING PHASE OF AN ENDOSCOPE PROCEDURE. SOME OF THIS FLUID SPURTED INTO THE EYE OF THE PHYSICIAN WHILE HANDLING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6073568 ↗