XPSRecalls & reported problems across all models
Medtronic Xomed, Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 156
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 6 models of XPS by Medtronic Xomed, Inc. in the FDA's device registry (GUDID). Together they are named in 156 adverse event reports in the FDA's MAUDE database, received between Dec 2, 2016 and Sep 29, 2026 — classified as 1 injury, 155 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (137 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
Reports received per month, all models
Most reported XPS problems
Device problems
- Overheating of Device137
- Noise, Audible13
- Vibration13
- Mechanical Jam11
- Intermittent Loss of Power3
- Mechanical Problem3
- Power Problem3
- Self-Activation or Keying3
Patient problems
- No Clinical Signs, Symptoms or Conditions125
- No Consequences Or Impact To Patient19
- No Patient Involvement10
- No Known Impact Or Consequence To Patient5
XPS models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- XPS® 1898200TDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE77 reports
- XPS® 1897200DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE45 reports
- XPS® 1898200TRFDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE25 reports
- XPS® 1898200TRFDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE6 reports
- XPS® 1895400DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE2 reports
- XPS® 1895410DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1 report
Recent XPS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Overheating of Device
It was reported that during use M4 handpiece was overheating. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930892 ↗MalfunctionSep 28, 2026Vibration
It was reported that M4 handpiece blade was wobble. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913845 ↗MalfunctionAug 27, 2026Overheating of Device
It was reported that pre-op, the M2 handpiece has heating issue. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50471566 ↗MalfunctionAug 26, 2026Vibration
It was reported that during an adenoid surgery, the handpiece vibrated and could not cut tissue normally. The procedure was completed normally after replacement with a backup handpiece. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50446054 ↗MalfunctionAug 11, 2026Vibration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50211850 ↗MalfunctionFeb 2, 2026Overheating of Device
IT WAS REPORTED THAT THE M4 HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24231405 ↗MalfunctionJan 18, 2026Break; Vibration
IT WAS REPORTED THAT PRE-OP, THE M4 HANDPIECE WAS NOT WORKING AND BLADE WOBBLING. BLADE WAS WORKING FINE WITH OTHER HANDPIECES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24106596 ↗MalfunctionDec 25, 2025Overheating of Device; Power Problem; Overheating of Device; Power Problem
IT WAS REPORTED THAT PRE-OP, THE HANDPIECE HAD A HEATING ISSUE OBSERVED WITHIN ONE MINUTE AT DEFAULT SPEED IN OSCILLATION MODE WITH IRRIGATION OF 25-30 CC/MM FLOW RATE AND STALLED DURING OSCILLATION MODE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23891573 ↗MalfunctionDec 8, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT, THE M4 WAS GETTING HOT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23739346 ↗MalfunctionNov 10, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT PRE-OP, THE M4 HANDPIECE WAS HEATING WHEN RAN FOR ABOUT A MINUTE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23519434 ↗MalfunctionSep 4, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT M4 QUIT SPINNING, GETS HOT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22974770 ↗MalfunctionAug 29, 2025Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT DURING PRE-OP, THE M4 HANDPIECE WAS NOT TUNING OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22921243 ↗MalfunctionAug 4, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING INTRA OPERATIVE THE M4 HANDPIECE WAS EMITTING HEAT. THE HANDPIECE WAS IN USE WHEN OVERHEATING WAS OBSERVED WITHIN LESS THAN ONE MINUTE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22697145 ↗MalfunctionJul 28, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING SETUP, THE M4 HANDPIECE WAS HEATING WHEN USED FOR LESS THAN A MINUTE. THE DEVICE WAS BEING RUN AT A SPEED OF 4000 RPM IN IN OSCILLATING MODE WHEN THE ISSUE OCCURRED. THE IRRIGATION WAS BEING USED WITH A FLOW RATE OF 50 CC/MIN. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22640022 ↗MalfunctionMay 26, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT PRE OP, DEVICE OVER HEATING. THERE IS NO PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22083119 ↗
Other Medtronic Xomed, Inc. products
All Medtronic Xomed, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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