HexaVue HexaVue FocusRecalls & reported problems
Black Diamond Video, Inc. · HexaVue Focus Integration System with Surgical Light Control · Class 2
All models of HexaVue (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00724995245054), received between Aug 5, 2026 and Sep 30, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (5 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
- Display or Visual Feedback Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Display or Visual Feedback Problem
The user facility reported that during a patient procedure, the multiport to their HexaVue Focus Integration System was not working, displaying no video from the input. The procedure was completed successfully with no delay. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946558 ↗MalfunctionSep 16, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794463 ↗MalfunctionSep 9, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50697860 ↗MalfunctionAug 27, 2026Display or Visual Feedback Problem
The user facility reported the monitors to their HexaVue Focus Integration Systems were ¿flickering¿. No report of procedure involvement. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50485769 ↗InjuryAug 5, 2026Display or Visual Feedback Problem
The user facility reported that during a patient procedure, the touch panel connected to their HexaVue Focus Integration System became unresponsive. The procedure was completed successfully after rebooting the system twice, causing a short delay. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50146929 ↗
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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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