DEFENDO Air/Water/Suction and Biopsy Valve 100316Recalls & reported problems
Medivators Inc. · 3-piece kit Single-Use Air Water, Suction and Biopsy Valves - Pentax · Class 2
All models of DEFENDO Air/Water/Suction and Biopsy Valve (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00677964055928), received between Jun 10, 2022 and Jan 11, 2024 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (4 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem7
- Difficult to Open or Close4
- Insufficient Device Problem Information3
- Physical Resistance/Sticking3
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Insufficient Information4
- Hematoma1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 11, 2024Difficult to Open or Close; Difficult to Open or Close
THE DISTRIBUTOR REPORTED THAT A SUCTION VALVE FROM THEIR DEFENDO VALVES & KITS "CAN NO LONGER BE RELEASED/CLOSED AFTER OPENING" DURING A PATIENT PROCEDURE RESULTING IN SUCTIONING OF THE MUCOUS MEMBRANE IN THE STOMACH AND BLEEDING. THE USER SWITCHED TO A DIFFERENT VALVE TO COMPLETE THE PROCEDURE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: Insufficient Information
MAUDE report 18499267 ↗MalfunctionJan 11, 2024Difficult to Open or Close; Difficult to Open or Close
THE DISTRIBUTOR REPORTED THAT A SUCTION VALVE FROM THEIR DEFENDO VALVES & KITS "CAN NO LONGER BE RELEASED/CLOSED AFTER OPENING" DURING A PATIENT PROCEDURE RESULTING IN SUCTIONING OF THE MUCOUS MEMBRANE IN THE STOMACH AND BLEEDING. THE USER SWITCHED TO A DIFFERENT VALVE TO COMPLETE THE PROCEDURE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: Insufficient Information
MAUDE report 18499076 ↗MalfunctionJan 11, 2024Difficult to Open or Close; Difficult to Open or Close
THE DISTRIBUTOR REPORTED THAT A SUCTION VALVE FROM THEIR DEFENDO VALVES & KITS "CAN NO LONGER BE RELEASED/CLOSED AFTER OPENING" DURING A PATIENT PROCEDURE RESULTING IN SUCTIONING OF THE MUCOUS MEMBRANE IN THE STOMACH AND BLEEDING. THE USER SWITCHED TO A DIFFERENT VALVE TO COMPLETE THE PROCEDURE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: Insufficient Information
MAUDE report 18499064 ↗MalfunctionDec 5, 2023Difficult to Open or Close; Insufficient Device Problem Information; Difficult to Open or Close; Insufficient Device Problem Information
THE DISTRIBUTOR REPORTED THAT SUCTION VALVES FROM THEIR DEFENDO VALVES & KITS "CAN NO LONGER BE RELEASED/CLOSED AFTER OPENING" DURING PATIENT PROCEDURES RESULTING IN SUCTIONING OF THE MUCOUS MEMBRANE IN THE STOMACH AND BLEEDING. THE USERS SWITCHED TO A DIFFERENT VALVE TO COMPLETE THE PROCEDURE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE DISTRIBUTOR STATED THE VALVES WERE USED BY FOUR DIFFERENT DOCTORS; HOWEVER, THEY WERE UNABLE TO PROVIDE THE EXACT NUMBER OF EVENTS AND DEVICES AFFECTED.
Patient problems: Insufficient Information
MAUDE report 18266336 ↗MalfunctionMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED VIA USER FACILITY MEDWATCH REPORT # (B)(4) THAT DURING PATIENT PROCEDURES WHICH INCLUDED USE OF A DEFENDO DISPOSABLE SUCTION VALVE, THE BUTTON OF THE VALVE WAS GETTING STUCK CAUSING CONSTANT SUCTION. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17011610 ↗MalfunctionMay 18, 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 16956577 ↗MalfunctionApr 24, 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. THE VALVE WAS REMOVED AND THE SUCTION STOPPED. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16797358 ↗MalfunctionFeb 1, 2023Physical Resistance/Sticking; 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. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16280376 ↗MalfunctionFeb 1, 2023Physical Resistance/Sticking; 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 MUCOUS MEMBRANE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16279935 ↗MalfunctionJan 20, 2023Physical Resistance/Sticking; 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 MUCOUS MEMBRANE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16214530 ↗MalfunctionNov 29, 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 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 15878783 ↗MalfunctionNov 15, 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 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 15799055 ↗MalfunctionOct 14, 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 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 SUCTIONING. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15611273 ↗MalfunctionJul 29, 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 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 15129122 ↗MalfunctionJul 29, 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 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 15128619 ↗MalfunctionJun 10, 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 INCLUDING USE OF A DEFENDO DISPOSABLE SUCTION VALVE, THERE WAS TOO MUCH SUCTION RESULTING IN A SMALL HEMATOMA. NO FURTHER MEDICAL TREATMENT WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF PROCEDURE DELAY.
Patient problems: Hematoma
MAUDE report 14653995 ↗
Other Endoscope Channel Accessory devices
- RX Locking Device and Biopsy Cap M00545260Boston Scientific Corporation · Endoscope channel accessory216 reports
- Orca™ SUV-617Boston Scientific Corporation · Endoscope Channel Accessory1 recall64 reports
- OrcaPod™ SUV-629Boston Scientific Corporation · Endoscope channel accessory112 reports
- andorate® Disposable Endoscope Valves Set GAR004GA Health Company Limited · Endoscope Channel Accessory1 recall1 report
- BullDog 1203-72Diversatek Healthcare, Inc. · Endoscope Channel Accessory1 recall0 reports
- Ruhof Scope Valet Guardian 345SVVO4Ruhof Corporation · Endoscope Channel Accessory1 recall0 reports
- 3-piece valve kit (Suction, Air/Water and Biopsy Valves) EN10229GA Health Company Limited · Endoscope Channel Accessory1 recall0 reports
- AutoCap™ RX M00545100Boston Scientific Corporation · Endoscope channel accessory26 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page