VISAO™ 3334635 (UDI 00643169955646)Recalls & reported problems
Medtronic Xomed, Inc. · GUARD 3334635 VISAO BUR W/IRRIGATION · Class 2
All models of ViSAO (16)
Data updated Oct 16, 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 00643169955646), received between Feb 7, 2025 and Feb 7, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Insert” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Insert1
- Overheating of Device1
- Vibration1
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.
MalfunctionFeb 7, 2025Difficult to Insert; Overheating of Device; Vibration; Difficult to Insert; Overheating of Device; Vibration
IT WAS REPORTED THAT PRIOR TO USE, THE VISAO DRILL HANDPIECE WAS OVERHEATING AFTER A FEW MINUTES OF USE, SHAKING DURING OPERATION, AND THE VISAO BUR GUARD WAS DIFFICULT TO INSERT THE DRILL INTO. THE ISSUE WAS NOT WITH THE DRILL BUT WITH THE ATTACHMENT, AND THE DRILL WORKED WELL. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21331222 ↗
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- RemB 6400015000Stryker Corporation · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE603 reports
- NA QD11Synthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE580 reports
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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