DEFENDO Defendo Fujifilm 700 Series (REF 100335)Recalls & reported problems
Medivators Inc. · Defendo for Fuji 700, 3-piece Single Use Valve Kit with Air Water, Suction, and Biopsy Valve. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00724995228958), received between Jul 9, 2026 and Jul 9, 2026 — classified as 1 malfunction.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2026Leak/Splash
THE DISTRIBUTOR REPORTED FROM A USER FACILITY THAT DURING A PATIENT PROCEDURE THE AIR/WATER VALVE AND BIOPSY VALVE TO THEIR DEFENDO SINGLE USE VALVE KIT LEAKED AND SPRAYED WATER ONTO USER FACILITY PERSONNEL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25770988 ↗
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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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