DEFENDO Air/Water/Suction and Biopsy ValveRecalls & reported problems across all models
Medivators Inc. · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 3 models of DEFENDO Air/Water/Suction and Biopsy Valve by Medivators Inc. in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Nov 2, 2016 and Aug 6, 2026 — classified as 2 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported DEFENDO Air/Water/Suction and Biopsy Valve problems
Device problems
- Adverse Event Without Identified Device or Use Problem7
- Insufficient Device Problem Information5
- Difficult to Open or Close4
- Physical Resistance/Sticking4
- Device Difficult to Setup or Prepare1
- Fluid/Blood Leak1
- Leak/Splash1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Insufficient Information4
- No Known Impact Or Consequence To Patient2
- Exposure to Body Fluids1
- Hematoma1
DEFENDO Air/Water/Suction and Biopsy Valve models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DEFENDO Air/Water/Suction and Biopsy Valve 100316Endoscope Channel Accessory16 reports
- DEFENDO Air/Water/Suction and Biopsy Valve 100305Endoscope Channel Accessory5 reports
- DEFENDO Air/Water/Suction and Biopsy Valve 100305Colonoscope and accessories, flexible/rigid1 report
Recent DEFENDO Air/Water/Suction and Biopsy Valve adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50154814 ↗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 ↗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 ↗
Other Medivators Inc. products
All Medivators Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
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