VISAO™ 3334635 (UDI 00885074107363)Recalls & reported problems
Medtronic Xomed, Inc. · GUARD 3334635 VISAO BUR W/IRRIGATION · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885074107363), received between Apr 14, 2017 and Apr 14, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2017Break; Break
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT NO FRAGMENT WAS DROPPED INSIDE THE PATIENT. THE DOCTOR USED ANOTHER BUR GUARD TO COMPLETE THE SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6493881 ↗MalfunctionApr 14, 2017Break; Break
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT NO FRAGMENT WAS DROPPED INSIDE THE PATIENT. THE DOCTOR USED ANOTHER BUR GUARD TO COMPLETE THE SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6493828 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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