DEFENDO Valve and Connector Kit 100315Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00677964055911), received between Aug 26, 2022 and Feb 8, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2024Suction Problem; Suction Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE INCLUDING USE OF A DEFENDO DISPOSABLE SUCTION VALVE, THERE WAS TOO MUCH SUCTION CAUSING THE ENDOSCOPE TO SUCTION TO THE PATIENT'S MUCOUS MEMBRANE. THE VALVE WAS REMOVED TO STOP THE SUCTION. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18671114 ↗
• MalfunctionJul 14, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE WATER JET CONNECTOR OF THEIR PENTAX VALVE KIT WAS SPRAYING WATER WHEN IN USE AND WAS ALSO DRIPPING WATER WHEN NOT IN USE. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17325560 ↗
• MalfunctionMar 31, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE INCLUDING USE OF A DEFENDO DISPOSABLE SUCTION VALVE, THERE WAS TOO MUCH SUCTION CAUSING THE ENDOSCOPE TO SUCTION TO THE PATIENT'S MUCOUS MEMBRANE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16654960 ↗
• MalfunctionMar 31, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE INCLUDING USE OF A DEFENDO DISPOSABLE SUCTION VALVE, THERE WAS TOO MUCH SUCTION CAUSING THE ENDOSCOPE TO SUCTION TO THE PATIENT'S MUCOUS MEMBRANE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16654957 ↗
• MalfunctionFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE INCLUDING USE OF A DEFENDO DISPOSABLE SUCTION VALVE, THERE WAS TOO MUCH SUCTION CAUSING THE ENDOSCOPE TO SUCTION TO THE PATIENT'S MUCOUS MEMBRANE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16279959 ↗
• MalfunctionDec 21, 2022Insufficient Device Problem Information; Physical Resistance/Sticking; Insufficient Device Problem Information; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE INCLUDING USE OF A DEFENDO DISPOSABLE SUCTION VALVE, THERE WAS TOO MUCH SUCTION CAUSING THE ENDOSCOPE TO SUCTION TO THE PATIENT'S MUCOSA RESULTING IN AN INJURY AND PROCEDURE DELAY. THE USER FACILITY DID NOT DISCLOSE IF FURTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Abrasion; Insufficient Information

  MAUDE report 16028624 ↗
• MalfunctionNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED DURING PATIENT PROCEDURES THE SUCTION VALVES FROM THEIR DEFENDO VALVE KITS ARE STICKING AND NOT RELEASING THE MUCOSA RESULTING IN PROCEDURE DELAYS. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15718858 ↗
• MalfunctionOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED DURING PATIENT PROCEDURES THE SUCTION VALVES FROM THEIR DEFENDO VALVE KIT ARE STICKING AND NOT RELEASING THE MUCOSA. USER FACILITY PERSONNEL REMOVE THE SUCTION BUTTON FROM THE SCOPE TO RELEASE THE MUCOSA. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591908 ↗
• MalfunctionSep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES WHICH INCLUDED USE OF THE DEFENDO - PENTAX VALVE KIT, THE SUCTION VALVE STICKS AND MAY REMAIN IN THE ON POSITION RESULTING IN SUCTION OF THE MUCOSAL AND A PROCEDURE DELAY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15481575 ↗
• MalfunctionAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE WHICH INCLUDED USE OF A DEFENDO PENTAX VALVE KIT, THE BIOPSY VALVE CAME OFF AND THE PHYSICIAN WAS SPRAYED WITH BODILY FLUIDS IN THE EYES CAUSING AN EYE INFECTION.

  Patient problems: Eye Infections

  MAUDE report 15303567 ↗