XPS StraightshotRecalls & reported problems across all models
Medtronic Xomed, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 356
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 2 models of XPS Straightshot by Medtronic Xomed, Inc. in the FDA's device registry (GUDID). Together they are named in 356 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Sep 28, 2026 — classified as 1 injury, 355 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (323 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 Straightshot problems
Device problems
- Overheating of Device323
- Noise, Audible28
- Vibration28
- Mechanical Jam22
- Use of Device Problem18
- Mechanical Problem8
- Connection Problem4
- Display or Visual Feedback Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions200
- No Consequences Or Impact To Patient98
- No Patient Involvement38
- No Known Impact Or Consequence To Patient24
- Insufficient Information4
- Burn(s)1
- Electric Shock1
XPS Straightshot models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- XPS® Straightshot® 1898200TDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE227 reports
- XPS® Straightshot® 1898200TDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE129 reports
Recent XPS Straightshot adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Break
It was reported that, the M4 was not working. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911500 ↗MalfunctionSep 24, 2026Overheating of Device
It was reported that intra operatively, after the 0-degree blade was opened, the procedure could not be completed because the handpiece malfunctioned, overheated, and stopped working. The overheating was noticed when used for less than one minute. The handpiece was run at 5000 rpm speed with reciprocating rotation mode and irrigation was being used. As a result, the surgery was not finished. The hospital then used another brand of powered system with a new blade head to restart the procedure and complete the surgery. There is suspicion of connection issue with the blade. There was delay of surgery for few minutes. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50879928 ↗MalfunctionAug 5, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50137304 ↗MalfunctionAug 3, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50113858 ↗MalfunctionJul 14, 2026Power Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25810841 ↗MalfunctionJul 5, 2026Overheating of Device
IT WAS REPORTED THAT PRE-OPERATION, THE M4 HANDPIECE WAS HEATING UP IN LESS THAN ONE MINUTE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25712530 ↗MalfunctionJun 26, 2026Overheating of Device
IT WAS REPORTED THAT PRE-OP, M4 HANDPIECE HAD HEATING ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25633084 ↗MalfunctionJan 7, 2026Overheating of Device; Connection Problem
IT WAS REPORTED THAT PRIOR TO USE, HANDPIECE HAD OVERHEATING ISSUE DUE TO ERROR CODE 16 AND THE PART IS NOT RECOGNIZED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23989429 ↗MalfunctionDec 26, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23894627 ↗MalfunctionNov 24, 2025Overheating of Device; Overheating of Device
ADDITIONAL INFORMATION RECEIVED AND INDICATED THAT THE BURN SKIN WAS LOOKED LIKE REDDENED BROKEN SKIN. GAUZE BANDAGE UNDER NOSE WAS USED TO ADDRESS THE BURN. ADDITIONAL INFORMATION RECEIVED FROM MEDTRONIC SERVICE AND REPAIR INDICATED THAT PERFORMED PRE-TEMPERATURE TEST AND AFTER 1 MIN TEMP ERATURE WERE GEAR 79.0, MOTOR 78 AND BEARING WERE 78 F.
Patient problems: Burn(s)
MAUDE report 23637821 ↗MalfunctionSep 8, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT PRIOR TO USE, HANDPIECE HAD MOTOR ISSUE AND HEATING ISSUE. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS BEING RUN AT 5000 RPM AND DEVICE WAS RUNNING IN OSCILLATION MODE AND OVERHEATED IN LESS THAN A MINUTE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22990471 ↗MalfunctionAug 21, 2025Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam
IT WAS REPORTED DURING PRE OP THE M4 HANDPIECE DID NOT MOVE/WORKED AND WAS OVERHEATING. THE HANDPIECE RAN ON THE OSCILLATION MODE, IRRIGATION WAS USED. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22857920 ↗MalfunctionJul 16, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE M4 HANDPIECE WAS OVERHEATING WITHIN 1 MIN. THE DEVICE WAS BEING RUN AT 5000 RPM IN OSCILLATE MODE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22522484 ↗MalfunctionJul 10, 2025Vibration; Vibration
IT WAS REPORTED THAT THE PART HAS A LOT OF VIBRATIONS. DURING TESTING, IT WAS OBSERVED THAT IT IS NOT POSSIBLE TO LOCK THE WHEEL THAT ALLOWS THE TOOL TO ROTATE 360, AND IT IS SUSPECTED THAT THE VIBRATIONS MAY BE CAUSED BY THIS ISSUE. THERE IS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22467031 ↗MalfunctionJun 24, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING USE HANDPIECE WAS OVERHEATING. THERE WAS NO KNOWN PATIENT IMPACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22313479 ↗
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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