Defendo Single Use Valve Kit 100313Recalls & reported problems
Medivators Inc. · Defendo Fujifilm 500 600 Air Water, Suction, and Biopsy Valve, 3-piece kit · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00677964094699), received between Sep 29, 2022 and Dec 14, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Physical Resistance/Sticking3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 14, 2022Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking
THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES INCLUDING USE OF THE DEFENDO VALVE KITS, THERE IS TOO MUCH SUCTION CAUSING THE ENDOSCOPES TO SUCTION TO THE MUCOSA RESULTING IN PROCEDURE DELAYS. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15982314 ↗MalfunctionSep 29, 2022Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking
THE USER FACILITY REPORTED DURING PATIENT PROCEDURES THE SUCTION VALVES FROM THEIR DEFENDO VALVE KIT ARE STUCK CAUSING THE MUCOSA TO BE SUCTIONED. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15505576 ↗MalfunctionSep 29, 2022Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking
THE USER FACILITY REPORTED DURING PATIENT PROCEDURES THE SUCTION VALVES FROM THEIR DEFENDO VALVE KIT ARE STUCK CAUSING THE MUCOSA TO BE SUCTIONED. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15505555 ↗
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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.
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