ViSAO® 31181598ERecalls & reported problems
Medtronic Xomed, Inc. · BUR 31181598E VISAO 1.5MM 98 L 20DG DIAM · Class 1
All models of ViSAO (16)
Data updated Oct 18, 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 00885074322223), received between Jan 12, 2017 and Dec 13, 2021 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break2
- Thermal Decomposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2021Break; Break
A DISTRIBUTOR REPORTED THAT AFTER DISASSEMBLY, SOME PARTS FELL OFF AND COULD NOT BE INSTALLED AND USED. THERE WAS NO PATIENT INVOLVEMENT. AS FOLLOW UP, IT WAS REPORTED THAT THE INCIDENT OCCURRED WHEN PREPARATIONS WERE MADE BEFORE THE OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12983096 ↗MalfunctionJan 12, 2017Break; Thermal Decomposition of Device; Break; Thermal Decomposition of Device
IT WAS REPORTED THAT THE DEVICE TIP WAS BURNED AND THE SHAFT OF THE BUR CAME OFF. THERE WAS NO REPORT OF PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6247653 ↗
Other BUR, EAR, NOSE AND THROAT devices
- Quadcut® 1884380HRMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall7 reports
- Silver Bullet® 1882905HREMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall3 reports
- Diego Elite MBUR6060FRCVGyrus ACMI, LLC · BUR, EAR, NOSE AND THROAT1 recall2 reports
- Quadcut® 1884380HREMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall1 report
- RAD® 1882916Medtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall1 report
- N/A 1882936EMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall0 reports
- N/A 1884033Medtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall0 reports
- Tricut® 1884033HREMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page