XPS® Straightshot® 1898200T (UDI 00885074080932)Recalls & reported problems
Medtronic Xomed, Inc. · MICRODEBRIDER 1898200T IGS M4 · Class 2
All models of XPS Straightshot (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic Xomed Straightshot microdebrider has 228 adverse event reports, including 227 malfunctions, 1 injury and no deaths. The reports mostly describe the handpiece overheating, sometimes before use, with some describing noise, vibration or jams. No recalls name this device. Reports fell from 16 in the previous 12 months to 5 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 227
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 227 adverse event reports that list this exact device (DI 00885074080932), received between Dec 21, 2016 and Aug 3, 2026 — classified as 1 injury, 226 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (205 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.
Reports received per month
Most reported problems
Device problems
- Overheating of Device205
- Noise, Audible22
- Vibration20
- Mechanical Jam13
- Use of Device Problem10
- Mechanical Problem6
- Connection Problem3
- Loose or Intermittent Connection2
Patient problems
- No Clinical Signs, Symptoms or Conditions117
- No Consequences Or Impact To Patient75
- No Patient Involvement24
- No Known Impact Or Consequence To Patient13
- Insufficient Information4
- Burn(s)1
- Electric Shock1
Recent adverse event reports
The 25 most recent of 227 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50113858 ↗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 ↗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 ↗MalfunctionMay 30, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE M4 HANDPIECE WAS OVERHEATING AND WILL NOT WORK. THERE WAS NO KNOWN PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 22112612 ↗MalfunctionMay 16, 2025Overheating of Device; Use of Device Problem; Overheating of Device; Use of Device Problem
IT WAS REPORTED THAT PRE-OP, THE M4 HANDPIECE WAS OVERHEATING WITHIN A MINUTE IN FORWARD MODE AT SPEED OF 6000R PM AND IRRIGATION USED AT 15CC/MIN. IT WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22036589 ↗MalfunctionMay 12, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING ESS PROCEDURE, M4 HANDPIECE HAD OVERHEATING ISSUE. THE PROCEDURE COMPLETED WITH ANOTHER PRODUCT. THE DEVICE WAS BEING RUN AT 5000 RPM AND IN OSCILLATION MODE. THE IRRIGATION FLOWRATE IS 10. THERE WAS NO KNOWN PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 22003430 ↗MalfunctionApr 29, 2025Vibration; Vibration
IT WAS REPORTED THAT DURING TESTING, M4 HANDPIECE WAS NOT SMOOTH AND VIBRATING AND IT IS CAUSING BLADE/BUR TO VIBRATE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21924311 ↗MalfunctionMar 14, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE M4 GETS WARM DURING USE AND THERE WAS SURGICAL DELAY. THERE WAS NO KNOWN PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 21603799 ↗MalfunctionMar 13, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING PROCEDURE M4 HANDPIECE WAS GETTING WARM. IT WAS FURTHER STATED THE DEVICE WAS RUN ON OSCILLATION MODE, IRRIGATION WAS BEING USED AND THERE WAS PROCEDURE DELAY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21590910 ↗MalfunctionMar 10, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT INTRA-OP, THE M4 HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21556638 ↗MalfunctionFeb 10, 2025Vibration; Vibration
IT WAS REPORTED THAT BEFORE OPERATION, THE BUR WOBBLING IN M4 HANDPIECE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21343076 ↗MalfunctionFeb 7, 2025Vibration; Vibration
IT WAS REPORTED THAT DURING PRE-OP, BUR WOBBLES WHEN USING WITH M4 HANDPIECE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21332411 ↗MalfunctionFeb 7, 2025Vibration; Vibration
IT WAS REPORTED THAT PRIOR TO PROCEDURE IN M4 HANDPIECE BUR WOBBLES. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21332306 ↗MalfunctionFeb 6, 2025Vibration; Vibration
IT WAS REPORTED THAT DURING PRE-OP, THE DEVICE HAD BUR WOBBLES. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21321234 ↗MalfunctionSep 2, 2024Vibration; Vibration
IT WAS REPORTED THAT PRIOR TO USAGE, WHEN THE BLADE OPERATES/MOVES OUTSIDE OF THE BODY, IT WOBBLES. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20116240 ↗MalfunctionAug 27, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE M4 HANDPIECE WAS GETTING HOT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20078565 ↗MalfunctionAug 4, 2024Overheating of Device; Use of Device Problem; Overheating of Device; Use of Device Problem
IT WAS REPORTED THAT TWO OF THE M4 HANDPIECES ARE NOT FUNCTIONING AS INTENDED. WHEN THE HANDPIECES ARE CONNECTED TO THE CONSOLE, ONE MOTOR IS NOT RESPONSIVE AND THE OTHER HEATS UP IMMEDIATELY AND CANNOT BE USED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19903457 ↗MalfunctionAug 4, 2024Overheating of Device; Use of Device Problem; Overheating of Device; Use of Device Problem
IT WAS REPORTED THAT TWO OF THE M4 HANDPIECES ARE NOT FUNCTIONING AS INTENDED. WHEN THE HANDPIECES ARE CONNECTED TO THE CONSOLE, ONE MOTOR IS NOT RESPONSIVE AND THE OTHER HEATS UP IMMEDIATELY AND CANNOT BE USED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19903456 ↗MalfunctionJul 26, 2024Overheating of Device; Overheating of Device
THE PRE-REPAIR TEMPERATURE TEST RESULTS WERE WITHIN 118F, WHICH ARE WITHIN SPECIFICATION AND MAKES THE EVENT NOT-REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19841915 ↗
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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.
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