DEFENDO 00711901Recalls & reported problems
US Endoscopy · The single-use DEFENDO Olympus EUS Air Water Suction Valve - Linear Biopsy Valve 3-piece kit · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00724995217402), received between Jul 27, 2026 and Aug 5, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
- Insufficient Device Problem Information1
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.
InjuryAug 5, 2026Leak/Splash
The user facility reported during a patient procedure their DEFENDO Olympus EUS Air Water Suction Valve Kit was "leaking" out of the distal tip of the scope, resulting in a procedure delay as the leak attributed to a loss in visualization. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50147728 ↗MalfunctionAug 5, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50144956 ↗MalfunctionJul 27, 2026Insufficient Device Problem Information
The user facility reported that during a patient procedure with the use of a DEFENDO Single Use Valve Kit, the balloon started deflating without the user depressing the suction valve subsequently causing water to leak into the patient. The procedure was completed successfully. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50000079 ↗
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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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