ViSAORecalls & reported problems across all models

We found 16 models of ViSAO by Medtronic Xomed, Inc. in the FDA's device registry (GUDID). Together they are named in 412 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2016 and Sep 11, 2026 — classified as 3 injuries, 409 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (322 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

Most reported ViSAO problems

ViSAO models

16 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Visao™ 3334800

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  262 reports
• VISAO® 3334800

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  65 reports
• VISAO® 3334800

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  55 reports
• Visao™ 3334800T

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  12 reports
• ViSAO® 31181098E

  BUR, EAR, NOSE AND THROAT
  5 reports
• VISAO™ 3334635

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  2 reports
• ViSAO® 31181598E

  BUR, EAR, NOSE AND THROAT
  2 reports
• VISAO® 3334800T

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  1 report
• VISAO™ 3334635

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  1 report
• ViSAO® 31152090E

  BUR, EAR, NOSE AND THROAT
  1 report
• ViSAO® 311910115E

  BUR, EAR, NOSE AND THROAT
  1 report
• ViSAO® 311920115E

  BUR, EAR, NOSE AND THROAT
  1 report
• ViSAO® 31202090E

  BUR, EAR, NOSE AND THROAT
  1 report
• ViSAO® 31151098E

  BUR, EAR, NOSE AND THROAT
  1 report
• ViSAO® 312120115E

  BUR, EAR, NOSE AND THROAT
  1 report
• Visao® 3318606

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  1 report

Recent ViSAO adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Vibration

  It was reported that during pre-op, The doctor installed the bur and performed a test. During operation, the motor produced an abnormal noise, the bur was wobbling. The doctor tried reinstalling the bur, but the issue persisted. Therefore, the doctor replaced the handpiece with a new one to complete the surgery. The same bur worked well with another handpiece. When other bur was tried with this handpiece, bur wobbled. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50728046 ↗
• 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 ↗
• MalfunctionJul 18, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22540360 ↗
• 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 ↗
• MalfunctionJun 3, 2025Vibration; Vibration

  IT WAS REPORTED THAT DURING THE OPERATION THE VISAO BALL TOOL WHIPS AND THE BALL TOOL DIDN¿T STAY IN THE AXIS OF ROTATION. THE CUSTOMER THINK THAT THE PROBLEM COME FROM EXTENDED BUR GUARD WITH IRRIGATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22129679 ↗
• MalfunctionMay 29, 2025Overheating of Device; Use of Device Problem; Overheating of Device; Use of Device Problem

  IT WAS REPORTED THAT DURING THE USE THE DEVICE HEATS UP AFTER USING IT FOR MORE THAN A MINUTE AND NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107586 ↗
• MalfunctionMay 26, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRE OP, THE DOCTOR INSTALLED THE HANDPIECE INTO THE IPC FOR TESTING AND FOUND THAT THE MOTOR OVERHEATED AFTER OPERATING FOR LESS THAN ONE MINUTE. THE DOCTOR TRIED TO TEST AGAIN BUT STILL OVERHEATED. FINALLY, THE DOCTOR CHANGED A HANDPIECE TO PROCEED WITH THE SURGICAL PROCEDURE. DEVICE BEING RUN AT A SPEED OF 80000 RPM AND IN FORWARD MODE AND IRRIGATION BEING USED. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22083088 ↗
• MalfunctionMay 5, 2025Vibration; Vibration

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21958721 ↗

Other Medtronic Xomed, Inc. products

• NIM Vital9 models · 1,696 reports · 4 recalls
• NIM-Response13 models · 974 reports
• Indigo6 models · 916 reports
• NIM TriVantage18 models · 541 reports · 2 recalls
• StraightShot6 models · 546 reports
• NIM15 models · 410 reports · 2 recalls
• XPS Straightshot2 models · 356 reports
• RAD29 models · 183 reports · 1 recall