STRAIGHTSHOT® 1899200 (UDI 00643169448131)Recalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 00643169448131), received between Feb 6, 2017 and Jul 22, 2026 — classified as 111 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (85 reports).

1 other recall cover devices cleared under the same FDA submission (K081277); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 111 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25900754 ↗
• MalfunctionJul 1, 2026Overheating of Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT PRIOR TO USE, THE M5 HANDPIECE WAS OVERHEATING AND FINGER SWITCH STUCK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25679052 ↗
• MalfunctionFeb 13, 2026Overheating of Device

  IT WAS REPORTED THAT PRE-OP, THE M5 HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331985 ↗
• MalfunctionJan 12, 2026Break; Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT THE HANDPIECE WAS NOISE, RATTLING, LAYER DEFECT, STUTTERING, AND HEATING UP QUICKLY. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED THAT EVENT OCCURRED BEFORE THE START OF THE SURGERY. THE OVERHEATING WAS OBSERVED AFTER 1 MINUTE. THE SPEED OF THE DEVICE WAS 12000 RPM, IN OSCILLATING MODE. THERE WAS BACKUP DEVICE USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24033245 ↗
• MalfunctionOct 27, 2025Overheating of Device; Vibration; Overheating of Device; Vibration

  IT WAS REPORTED THAT HANDPIECE WAS VIBRATING AND HAD OVERHEATING ISSUE. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23388647 ↗
• MalfunctionAug 26, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SETUP, WHILE TESTING IN A CADAVERIC TRAINING COURSE, THE M5 HANDPIECE GOT OVERHEATED WHEN USED FOR LESS THAN A MINUTE. THE HANDPIECE WAS RUNNING AT LOW SPEED (5,000 RPM) IN OSCILLATE MODE WITH 30 CC OF IRRIGATION. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891985 ↗
• MalfunctionMay 26, 2025Vibration; Vibration

  IT WAS REPORTED THAT DURING THE OPERATION, THE DEVICE WAS SPINNING MID-WAY. THE BURR WAS WOBBLING IN THE HANDPIECE WHEN THEY WERE USING IT. THERE WAS NO PATIENT IMPACT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22082951 ↗
• MalfunctionMay 16, 2025Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  IT WAS REPORTED THAT MOTOR OVERHEATS AND THE HANDPIECE IS BLOCKED. THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22033583 ↗
• MalfunctionMay 9, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING TESTING, THE M5 HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994545 ↗
• MalfunctionMay 2, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT M5 WAS OVERHEATING WHILE IN USE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21947667 ↗
• MalfunctionMar 30, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT INTRA OPERATIVELY, THE M5 DEVICE WAS OVERHEATING IN LESS THAN ONE MINUTE IN 1500 OSCILLATION MODE AT 1200 RPM SPEED. IRRIGATION WAS USED WITH A FLOW RATE OF 30CC/MIN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21728597 ↗
• MalfunctionMar 28, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRE-OP, THE M5 HANDPIECE HAD NO MOTOR SOUND OR ACTION AND IT WAS OVERHEATING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718006 ↗
• MalfunctionMar 24, 2025Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  IT WAS REPORTED THAT INTRA-OPERATIVELY, SURGEON STATED THAT THE HANDPIECE WAS NOT USED, AND THE ERROR MESSAGE 15 APPEARED BEFORE THEY STARTED THE SURGERY AND DEVICE WAS OVERHEATING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676422 ↗
• MalfunctionMar 17, 2025Vibration; Noise, Audible; Vibration; Noise, Audible

  IT WAS REPORTED THAT AFTER SET UP, THE M5 HANDPIECE HAD A CLICKING NOISE AND VIBRATING WHEN ACTIVE. THE HANDPIECE CAUSE THE BLADE TO VIBRATE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617184 ↗
• MalfunctionFeb 25, 2025Inability to Irrigate; Overheating of Device; Inability to Irrigate; Overheating of Device

  IT WAS REPORTED THAT DURING USE, M5 HANDPIECE HEATED UP, DID NOT IRRIGATE AND ERROR 15, 11 WAS APPEARED ON THE CONSOLE WHEN THE PEDAL WAS PRESSED. USER DID NOT HAVE ANOTHER HANDPIECE TO TEST. FOOT SWITCH DID NOT HAVE ANY ISSUE WHEN TESTED WITH ANOTHER CONSOLE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21456246 ↗
• MalfunctionFeb 7, 2025Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  IT WAS REPORTED THAT A DEVICE BECAME WARM AND STUCK. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21331285 ↗
• MalfunctionJan 6, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRIOR TO USE, THE M5 HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21077493 ↗
• MalfunctionNov 23, 2024Overheating of Device; Overheating of Device

  ADDITIONAL INFORMATION RECEIVED AND INDICATING THAT THE EVENT OCCURRED DURING PRIOR TO USE. THE DEVICE WAS OVERHEATING IN LESS THAN A MINUTE. THE DEVICE WAS RUNNING AT 500 RPM IN OSCILLATE MODE. THE FLOW RATE OF IRRIGATION WAS 5 CC/MINUTE. THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20766307 ↗
• MalfunctionNov 11, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRE-OP, M5 HANDPIECE HAD OVERHEATING ISSUE. THERE WAS NO PATIENT INVOLVED. THE EVENT OCCURRED JUST BEFORE THE SURGERY. IT TOOK LESS THAN A MINUTE TO OVERHEAT. THEY USED ANOTHER SHAVER TO COMPLETE THE SURGERY. IRRIGATION WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20650439 ↗
• MalfunctionOct 22, 2024Vibration; Mechanical Jam; Vibration; Mechanical Jam

  IT WAS REPORTED THAT PRIOR TO USE, BLADE WAS STUCK AND M5 HANDPIECE WAS VIBRATING BUT NOT ROTATING WHEN TRYING TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20508776 ↗
• MalfunctionOct 1, 2024Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  IT WAS REPORTED THAT PREOPERATIVELY, THE DEVICE STALLS WITH ERROR CODE 15 AND GETS HEATED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20341402 ↗
• MalfunctionSep 30, 2024Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT DURING USE M5 HANDPIECE WAS MAKING LOUD NOISE AND RUNNING HOT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20332102 ↗
• MalfunctionSep 23, 2024Vibration; Noise, Audible; Vibration; Noise, Audible

  IT WAS REPORTED THAT PREOPERATIVELY, THE HANDPIECE WAS VIBRATING AND MAKING GRINDING NOISE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20276381 ↗
• MalfunctionJul 1, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT INTRA-OPERATIVELY DURING SINUS CASE, THE M5 HANDPIECE OVERHEATED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19641620 ↗
• MalfunctionMay 20, 2024Use of Device Problem; Vibration; Noise, Audible; Use of Device Problem; Vibration; Noise, Audible

  IT WAS REPORTED THAT DURING INTRA-OP, THE M5 DEBRIDER WAS MAKING NOISES, THAT WERE NOT NORMAL WHEN A BURR WAS ATTACHED. THE DEBRIDER WAS TEMPERAMENTAL WHEN WORKING AND HAD MORE SPORADIC MOMENTS OF WORKING THAN NOT, WHICH IS NOT SUITABLE IN SURGERY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19348967 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081277. One submission often covers many models, so check the product and lot details in each record.

• Z-0961-2022 · Dec 15, 2021 · Terminated
  Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND E