XPS® 1898200TRecalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 00643169882706), received between Apr 4, 2020 and Sep 29, 2026 — classified as 77 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (66 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 77 reports, 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 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 ↗
• 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 ↗
• MalfunctionMay 13, 2025Vibration; Noise, Audible; Vibration; Noise, Audible

  ADDITIONAL INFORMATION RECEIVED THAT THE THEY DID TRY ANOTHER HANDPIECE WITH THE BLADE AND DECIDED IT WAS THE HANDPIECE AND NOT THE BLADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22007848 ↗
• MalfunctionMar 17, 2025Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  IT WAS REPORTED THAT IN M4 HANDPIECE THE BLADE DOES NOT TURN AND DEVICE OVERHEATS. IT WAS FURTHER STATED THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21615720 ↗
• MalfunctionFeb 6, 2025Vibration; Vibration

  IT WAS REPORTED THAT PRIOR TO USE, THE BUR WOBBLES. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21319421 ↗
• MalfunctionDec 10, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING PRE-OP, THE HANDPIECE WAS RUNNING AT 5000RPM IN FORWARD MODE AND WITHIN ONE MINUTE IT HAD HEATING ISSUE. IRRIGATION WAS USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER HANDPIECE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20893743 ↗
• MalfunctionDec 4, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRIOR TO USE, THE M4 HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20840284 ↗
• MalfunctionOct 24, 2024Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT WHEN THE DISTRIBUTOR PERFORMED THE ROUTINE MAINTENANCE, IT FOUND THAT THE M4 HANDPIECE MOTOR HAS STRANGE SOUND AND WILL GET HOT IN LESS THAN ONE MINUTE WHEN IN FWD MODE AT 12000 RPM WITH 30 CC/MIN IRRIGATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20520321 ↗
• MalfunctionOct 1, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT WHEN THE DEALER PERFORMED THE ROUTINE MAINTENANCE, IT FOUND THAT THE MOTOR HAS STRANGE SOUND AND WILL GET HOT WHEN IN FWD MODE. THERE IS NO PATIENT INVOLVED IN THIS EVENT. OVER HEATING WAS NOTICED WHEN DEVICE BEING USED LESS THAN A MINUTE. DEVICE WAS BEING RUN AT AT 12000RPM IN FORWARD MOTION BY USING IRRIGATION OF 30CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343585 ↗
• MalfunctionSep 18, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT BEFORE OPERATION, THE M4 HANDPIECE HAD AN EXCESSIVE HEAT. THE M4 HANDPIECE WAS BEING USED LESS THAN ONE MINUTE WHEN THE OVERHEATING WAS NOTICED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20244210 ↗
• MalfunctionSep 3, 2024Overheating of Device; Overheating 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 20125999 ↗
• MalfunctionJul 18, 2024Overheating of Device; Intermittent Energy Output; Overheating of Device; Intermittent Energy Output

  IT WAS REPORTED THAT INTRA-OP, THE M4 HANDPIECE WAS OVERHEATING AND IT CANNOT ROTATE AT A CONSTANT SPEED, INTERMITTENTLY STOPPING. THE HANDPIECE WAS USED FOR LESS THAN A MINUTE. THE DEVICE WAS BEING RUN AT 12000 RPM IN FORWARD MODE. IRRIGATION WAS BEING USED AT THE FLOW RATE 50CC/MIN. THE PROCEDURE WAS COMPLETED USING BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19769927 ↗
• MalfunctionJul 8, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRE-OP, M4 HANDPIECE WAS OVERHEATING ABOUT ONE MINUTE. PROCEDURE WAS COMPLETED WITH BACK-UP PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19687696 ↗
• MalfunctionApr 8, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT MOTOR HEAT UP DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION STATES THAT DEVICE WAS OVERHEATING WITHIN A MINUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19062767 ↗