HexaVueRecalls & reported problems across all models
Black Diamond Video, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 346
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls
- 0
We found 5 models of HexaVue by Black Diamond Video, Inc. in the FDA's device registry (GUDID). Together they are named in 346 adverse event reports in the FDA's MAUDE database, received between Apr 26, 2023 and Sep 30, 2026 — classified as 18 injuries, 328 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (317 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported HexaVue problems
Device problems
- Display or Visual Feedback Problem317
- Insufficient Device Problem Information6
- Computer Software Problem2
- Connection Problem2
- Failure to Power Up2
- Misconnection2
- No Audible Prompt/Feedback2
- No Display/Image2
Patient problems
- No Clinical Signs, Symptoms or Conditions345
- Pain1
HexaVue models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HexaVue HexaVue SCC 1.0CAMERA, SURGICAL AND ACCESSORIES245 reports
- HexaVue HexaVue IPCAMERA, SURGICAL AND ACCESSORIES80 reports
- HexaVue HexaVue-SLC 1.0Light, surgical, accessories9 reports
- HexaVue HexaVue IPLight, surgical, accessories7 reports
- HexaVue HexaVue FocusLight, surgical, accessories5 reports
Recent HexaVue adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952754 ↗MalfunctionSep 30, 2026Display or Visual Feedback Problem
The user facility reported that the monitor to their HexaVue Custom Room Rack was lagging causing a distorted image display. This event did not occur during a patient procedure. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946695 ↗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 28, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923829 ↗MalfunctionSep 24, 2026Display or Visual Feedback Problem
The user facility reported that during a patient procedure the monitors connected to their HexaVue Custom Room Rack ¿went black and then came back on¿. The patient procedure was completed successfully. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884712 ↗MalfunctionSep 24, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884044 ↗MalfunctionSep 24, 2026Unintended Movement
The user facility reported that prior to a patient procedure the monitors to their HexaVue Custom Room Rack were experiencing intermittent blinking. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883980 ↗MalfunctionSep 24, 2026Display or Visual Feedback Problem
The user facility reported that a monitor and wall display connected to their HexaVue Custom Room Rack were ¿flickering¿. No report of procedure involvement. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883723 ↗MalfunctionSep 24, 2026Display or Visual Feedback Problem
The user facility reported during a patient procedure the monitor to their HexaVue IP Custom Room Rack was experiencing a routing issue that attributed to the surgical display images ¿dropping¿ and ¿going black¿. No report of procedure delay. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876739 ↗MalfunctionSep 23, 2026Display or Visual Feedback Problem
The user facility reported the touch panel to their HexaVue Custom Room Rack was distorted with red lines. No report of procedure involvement. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872049 ↗MalfunctionSep 23, 2026Display or Visual Feedback Problem
The user facility reported that the HexaVue Integration System for their HexaVue Custom Room Rack was experiencing intermittent image capture issues. This event did not occur during a procedure. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870995 ↗InjurySep 23, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869385 ↗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 28, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50497516 ↗
Other Black Diamond Video, Inc. products
All Black Diamond Video, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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