DEFENDO SINGLE USE VALVE KIT 100323Recalls & reported problems
Medivators Inc. · The Defendo Sigle Use Valve kit 4-piece kit includes Air Water, Suction and Biopsy Valves and a Cleaning Adapter. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00724995246839), received between Aug 13, 2026 and Aug 13, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Leak/Splash” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- Foreign Body Sensation in Eye1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 13, 2026Leak/Splash
The user facility reported that while utilizing the Biopsy Valve to their Defendo Single Use Valve Kit, the water ¿bubbled back up through the cap¿ and sprayed two employees in the face. The employees went to an eye washing station and flushed their eyes. No additional treatment was sought or administered.
Patient problems: Foreign Body Sensation in Eye
MAUDE report 50237602 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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