DEFENDO Valve and Connector Kit 100310 (UDI 00677964052453)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00677964052453), received between Sep 1, 2017 and Feb 26, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Leak/Splash

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE WATER WAS LEAKING FROM THEIR DEFENDO DISPOSABLE AIR/WATER VALVES. USER FACILITY PERSONNEL CHANGED THE VALVES, TUBING, AND LOWERED THE WATER LEVEL WITHIN THEIR DEFENDO DISPOSABLE AIR/WATER VALVE RESULTING IN A PROCEDURE DELAY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24460796 ↗
• MalfunctionJun 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY REPORTED VIA VIGILANCE REPORT TO ANSM THAT THEIR DEFENDO SUCTION VALVE WAS NOT WORKING PRIOR TO USE IN A PROCEDURE. USER FACILITY PERSONNEL OBTAINED A NEW VALVE TO COMPLETE THE PROCEDURE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528495 ↗
• MalfunctionNov 17, 2023Break; Break

  THE DISTRIBUTOR REPORTED THAT THE SUCTION VALVE FROM THEIR DEFENDO VALVES & KITS WAS STUCK IN THE DEPRESSED POSITION DURING A PATIENT PROCEDURE. THE VALVE BROKE AS USER FACILITY PERSONNEL ATTEMPTED TO PULL IT OUT CAUSING HALF OF THE VALVE TO BECOME STUCK IN THE ENDOSCOPE. A PROCEDURE DELAY OCCURRED AS USER FACILITY PERSONNEL EXCHANGED THE ENDOSCOPE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18159937 ↗
• MalfunctionAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT DURING MULTIPLE PATIENT PROCEDURES WHICH INCLUDED USE OF THE DEFENDO - OLYMPUS VALVE KIT, THE TISSUE SAMPLE GOT STUCK IN THE BIOPSY VALVE WHEN REMOVING THE FORCEPS FROM THE BIOPSY VALVE RESULTING IN A PROCEDURE DELAY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15297929 ↗
• InjuryFeb 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE FACILITY REPORTED THAT DURING AN EGD ENDOSCOPY PROCEDURE, THE PATIENT EXPERIENCED VOCAL CORD MUSCLE SPASMS. THE DISPOSABLE DEFENDO AIR/WATER VALVE WAS USED DURING THE PROCEDURE AND WAS REPORTED TO HAVE CONTRIBUTED TO THE EVENT.

  Patient problems: Airway Obstruction; Muscle Spasm(s)

  MAUDE report 8343345 ↗
• InjuryJun 13, 2018Improper or Incorrect Procedure or Method; Device Handling Problem; Improper or Incorrect Procedure or Method; Device Handling Problem

  A MEDIVATORS ACCOUNT MANAGER REPORTED A FACILITY REPROCESSING, THEN REUSING DEFENDO DISPOSABLE AIR/WATER, SUCTION, AND BIOPSY VALVES BETWEEN USES IN PATIENT PROCEDURE. THE DEFENDO AIR/WATER, SUCTION AND BIOPSY VALVE IS INTENDED FOR SINGLE USE, THUS POTENTIAL FOR PATIENT CROSS-CONTAMINATION.

  Patient problems: Exposure to Body Fluids

  MAUDE report 7598694 ↗
• InjurySep 1, 2017Device Contamination with Body Fluid; Device Contamination with Body Fluid

  A FACILITY REPORTED BLOOD/FLUID BACKFLOW IN THE TUBING TO THE PUMP DURING A PROCEDURE USING MEDIVATORS AUXILIARY WATER JET CONNECTOR. THERE IS POTENTIAL FOR PATIENT CROSS CONTAMINATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6839309 ↗