Visao™ 3334800Recalls & reported problems

Summary

The FDA's MAUDE database contains 262 adverse event reports that list this exact device (DI 00885074107332), received between Dec 6, 2016 and Jan 2, 2026 — classified as 262 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (212 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 262 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2026Overheating of Device

  IT WAS REPORTED THAT PREOPERATIVE, HANDPIECE WAS INSTALLED ONTO THE IPC FOR TESTING, FOUND THAT THE BUR LOCK PLACE BECAME HOT IN LESS THAN 30 SECONDS WHILE THE MOTOR WAS RUNNING. THEY TRIED TO RECONNECT THE HANDPIECE AND BUR BUT THE PROBLEM STILL EXISTED. FINALLY, CHANGED HANDPIECE WITH BACKUP ONE AND THIS WAS FUNCTIONING NORMALLY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23952327 ↗
• MalfunctionDec 1, 2025Overheating of Device; Use of Device Problem; Overheating of Device; Use of Device Problem

  IT WAS REPORTED THAT INTRA-OP, THE VISAO DRILL WAS RUNNING HOT AND NOT RUNNING RIGHT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677720 ↗
• MalfunctionDec 1, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT INTRA OPERATIVE, HANDPIECE WAS RUNNING HOT AND NOT RUNNING RIGHT. THERE WAS NO PATIENT IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677672 ↗
• MalfunctionNov 25, 2025Overheating of Device; Use of Device Problem; Overheating of Device; Use of Device Problem

  IT WAS REPORTED THAT PRE-OP, THE VISAO DRILL MOTOR WAS NOT WORKING PROPERLY AND OVERHEATING. THE HANDPIECE WAS BEING RUN AT 80000 RPM IN FORWARD MODE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644159 ↗
• MalfunctionNov 25, 2025Overheating of Device; Vibration; Overheating of Device; Vibration

  IT WAS REPORTED THAT DURING SET UP, HANDPIECE HAD VIBRATION ISSUE. THERE WAS NO PATIENT IMPACT. DURING ANALYSIS HANDPIECE FOUND TO BE OVERHEATING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23642349 ↗
• MalfunctionOct 15, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT BEFORE OPERATION, THE VISAO DRILL WAS OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23287312 ↗
• MalfunctionOct 14, 2025Vibration; Vibration

  IT WAS REPORTED THAT PRE-OP, BUR WAS WOBBLING WHEN USED WITH VISAO. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23275974 ↗
• MalfunctionJul 23, 2025Vibration; Vibration

  IT WAS REPORTED THAT BEFORE OPERATION THE BUR WAS WOBBLING IN VISAO. THE BUR WAS WORKING FINE IN ANOTHER HANDPIECE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22573045 ↗
• MalfunctionJun 10, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DEVICE WAS NOT COOLING PROPERLY/HEATING ISSUE. THERE IS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174862 ↗
• MalfunctionApr 21, 2025Overheating of Device; Overheating of Device

  ADDITIONAL INFORMATION RECEIVED: EVENT OCCURRED DURING SETUP AND INTRA-OP. OVERHEATING WAS NOTIFIED MORE THAN A MINUTE. IRRIGATION WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21870611 ↗
• MalfunctionFeb 10, 2025Vibration; Vibration

  IT WAS REPORTED THAT PRE-OP, THE VISAO DRILL BUR WOBBLES. THE BUR USED WITH ANOTHER HANDPIECE AND WORKED FINE AND THE HANDPIECE USED WITH ANOTHER BUR AND NOT WORKED FINE. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21342311 ↗
• MalfunctionFeb 10, 2025Vibration; Vibration

  IT WAS REPORTED THAT BEFORE OPERATION, THE BUR WAS WOBBLING IN VISAO HANDPIECE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21342062 ↗
• MalfunctionFeb 10, 2025Vibration; Vibration

  IT WAS REPORTED THAT PRIOR TO USE, BUR WOBBLES IN VISAO DRILL. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21342007 ↗
• MalfunctionFeb 10, 2025Vibration; Vibration

  IT WAS REPORTED THAT BEFORE OPERATION THE BUR WOBBLING IN VISAO DRILL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341736 ↗
• MalfunctionFeb 7, 2025Vibration; Vibration

  IT WAS REPORTED THAT BEFORE OPERATION, BUR WAS WOBBLING IN VISAO HANDPIECE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332464 ↗
• MalfunctionFeb 7, 2025Vibration; Mechanical Jam; Vibration; Mechanical Jam

  IT WAS REPORTED THAT PRIOR TO USE, THE VISAO HANDPIECE MOTOR DOES NOT TURN AND THE BUR WOBBLES IN IT. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332299 ↗
• MalfunctionFeb 7, 2025Vibration; Vibration

  IT WAS REPORTED THAT PRIOR TO USE, THE BUR WOBBLES. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21330206 ↗
• MalfunctionFeb 6, 2025Vibration; Vibration

  IT WAS REPORTED THAT PRE-OP, THE VISAO DRILL BUR WOBBLES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21320570 ↗
• MalfunctionFeb 6, 2025Vibration; Vibration

  IT WAS REPORTED THAT DURING PRE-OP, THE DEVICE HAD OSCILLATION DURING ROTATION, INDUCED BUR DEVIATION. VIBRATION FROM THE MOTOR CAUSED THE BUR SHAKING WHILE HANDPIECE WAS ACTIVE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21320409 ↗
• MalfunctionFeb 4, 2025Vibration; Vibration

  IT WAS REPORTED THAT DUTING SETUP, THE BUR WOBBLES IN VISAO HANDPIECE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304653 ↗
• MalfunctionFeb 4, 2025Vibration; Noise, Audible; Vibration; Noise, Audible

  IT WAS REPORTED THAT PRE-OP, THE VISAO DRILL HANDPIECE WAS NOISY AND BUR WAS WOBBLING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21301084 ↗
• MalfunctionFeb 3, 2025Overheating of Device; Overheating of Device

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE OVERHEATING WAS NOTICED WHEN THE DRILL WAS USED FOR 10 MINUTES. THE HANDPIECE WAS RUN AT A SPEED OF 80K IN DRILL MODE AND IRRIGATION WAS BEING USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21290920 ↗
• MalfunctionJan 13, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRE-OP, THE VISAO HANDPIECE WAS GETTING HOT WITHIN A MINUTE WHILE RUNNING AT 30,000 RPM IN FORWARD MODE WITH AN IRRIGATION RATE OF 30 CC/MIN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137404 ↗
• MalfunctionNov 15, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT INTRA-OP, THE VISAO DRILL WAS OVERHEATING. THE OVERHEATING OF DRILL WAS NOTICED ABOUT ONE MINUTE. THE PROCEDURE WAS COMPLETED WITH BACK-UP DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20696338 ↗
• MalfunctionNov 6, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT BEFORE THE OPERATION, THE VISAO HANDPIECE HAD EXCESSIVE HEAT. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20618708 ↗