DEFENDO Disposable Biopsy Valve 100302Recalls & reported problems
Medivators Inc. · DEFENDO Disposable Biopsy Valve for PENTAX GI Endoscopes · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00677964060267), received between May 2, 2025 and May 29, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED VIA VIGILANCE REPORT THAT THEIR DEFENDO BIOPSY VALVE LEAKED. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22108549 ↗MalfunctionMay 15, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED VIA VIGILANCE REPORT THAT THEIR DEFENDO BIOPSY VALVE LEAKED. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22030782 ↗MalfunctionMay 13, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED VIA VIGILANCE REPORT THAT THEIR DEFENDO BIOPSY VALVE LEAKED. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22009283 ↗MalfunctionMay 2, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED VIA VIGILANCE REPORT THAT THEIR DEFENDO BIOPSY VALVE LEAKED. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21954137 ↗
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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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