AEXTM 40-405-1 (UDI 00643169531048)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00643169531048), received between Apr 15, 2019 and Aug 27, 2026 — classified as 2 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Failure to Shut Off” (6 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Electromagnetic Interference

  Information was received from a healthcare provider regarding a generator. It was reported that the generator was experiencing large EF interference in a cath lab. Several RF leakage tests were performed, found none. Monopolar output tests were also performed, all settings behaved as normal. A patient was involved but there was no reported impact on the patient outcome.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50472208 ↗
• MalfunctionAug 16, 2026Electromagnetic Interference

  Information was received from a healthcare provider regarding a generator. It was reported that the generator was interfering with ECG signal when the handpiece was used. Moving the grounding pad from the patient's back to their leg reduced the interference. A patient was involved but there was no reported impact on the patient outcome.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50264264 ↗
• MalfunctionMay 26, 2026Electromagnetic Interference

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT, DURING AN INTRA-OPERATIVE USE PERFORMING EKG, A LOT OF ARTIFACT WAS OBSERVED WHEN THE GROUNDING PAD WAS CONNECTED. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25275416 ↗
• MalfunctionJan 19, 2026Failure to Shut Off

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THE SURGEON WOULD LET GO OF THE HAND PIECE BUTTONS BUT THE HANDPIECE WOULD STAY ACTIVATED FOR A FEW SECONDS AFTERWARDS. SITE TESTED THE SAME HANDPIECE ON THE SAME GENERATOR AFTERWARDS AND WAS UNABLE TO REPLICATE BEHAVIOR. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24112114 ↗
• MalfunctionJan 9, 2026Output above Specifications; Output below Specifications

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THA T DURING TESTING THE DEVICE WAS OUTPUTTING VALUES OUT OF SPEC. NO PATIENT PRESENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE OUTPUT WAS ABOVE SPEC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24025262 ↗
• MalfunctionDec 8, 2025Failure to Shut Off; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT DURING PM TESTING OF THE GENERATOR, AN UNEXPECTED RESULT OCCURRED IN WHICH THE GROUNDING INDICATOR WAS RED WHEN TESTING WITH AN ESA AND DECADE BOX. TROUBLESHOOTING INCLUDED SETTING THE DECADE BOX TO 0 AND ADJUSTING THE ESA BETWEEN THE SETTINGS IN THE MANUAL, BUT THE GROUNDING INDICATOR REMAINED RED. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744158 ↗
• MalfunctionJun 9, 2025Activation Problem; Activation Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT DURING A LUMPECTOMY PROCEDURE, THE HANDPIECE WAS SWITCHING FROM COAG TO CUT WITHOUT PROMPT. ANOTHER HANDPIECE FUNCTIONED AS INTENDED. THERE WAS NO REPORTED IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168815 ↗
• MalfunctionJun 6, 2025Output above Specifications; Output above Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT MEASUREMENTS WERE OUT OF TOLERANCE FOR CUT 1, 2, 3, 4, AND 5 ON THE GENERATOR. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22159135 ↗
• MalfunctionJun 4, 2025Output above Specifications; Output above Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT WHEN TESTING THE GENERATOR, THE CUT 1-3 SETTINGS WERE HIGHER THAN THE SPECIFICATIONS. THE TESTING EQUIPMENT WAS ABLE TO TEST AT THESE RANGES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22141637 ↗
• MalfunctionMay 7, 2025Activation Problem; Activation Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT DURING A LUMPECTOMY PROCEDURE, THE HANDPIECE WAS UNRESPONSIVE, SWITCHING FROM COAG TO CUT. THE ISSUE OCCURRED INTRAOPERATIVELY, CASE CONTINUED BY OPENING UP ANOTHER HANDPIECE, AND THE ISSUE WAS RESOLVED. THERE WAS NO REPORTED IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21975122 ↗
• MalfunctionApr 30, 2025Activation Problem; Activation Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT DURING A LUMPECTOMY PROCEDURE, THE HANDPIECE WAS UNRESPONSIVE, SWITCHING FROM COAG TO CUT. THE ISSUE OCCURRED INTRAOPERATIVELY, ANDCASE CONTINUED BY OPENING UP ANOTHER HANDPIECE, AND THE ISSUE WAS RESOLVED. THERE WAS NO REPORTED IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932586 ↗
• MalfunctionJan 9, 2025Electromagnetic Interference; Electromagnetic Interference

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR AND HANDPIECE. IT WAS REPORTED THAT DURING A GENERATOR REP LACEMENT PROCEDURE INVOLVING THE PACEMAKER, ADDITIONAL PACING SPIKES WERE OBSERVED ON THE SCREEN WITH ELECTROCARDIOGRAM MONITORING WHEN A HANDPIECE WAS USED. THE DEVICE WAS PROGRAMMED TO DUAL CHAMBERED ASYNCHRONOUS PACING (DOO) 70, BUT ADDITIONAL PACING SPIKES, INCLUDING R ON T, WERE NOTED DESPITE THE PROGRAMMING OF DOO 60, DOO 70, AND DOO 90. ELECTROMAGNETIC INTERFERENCE FROM THE HANDPIECE WAS IDENTIFIED AS THE SOURCE OF THE ADDITIONAL PACING SPIKES. AFTER REPLACING THE PACEMAKER WITH A NEW ONE, NO ADDITIONAL PACING WAS OBSERVED UNDER THE SAME CONDITIONS. NO ADVERSE REACTION OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112618 ↗
• MalfunctionFeb 7, 2024Failure to Shut Off; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM AN MANUFACTURER REPRESENTATIVE (REP) REGARDING A GENERATOR. IT WAS REPORTED THAT THE ENERGY WAS NOT SHUTTING OFF AFTER THE BUTTON WAS PRESSED. THE COAG BUTTON WAS STICKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660019 ↗
• MalfunctionNov 9, 2023Output above Specifications; Output above Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT WHILE DOING THE ANNUAL PREVENTATIVE MAINTENANCE (PM) THE SITE FOUND THAT CUT 8 AND COAG 5 WERE MEASURING OUTSIDE OF THE TOLERANCES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18102944 ↗
• MalfunctionAug 29, 2023Failure to Shut Off; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT THE SITE WAS HAVING ISSUES WITH A HANDPIECE WHERE THE COAG FUNCTION WOULD CONTINUE 30 SECONDS AFTER THEY RELEASED THE BUTTON. THE SITE SWITCHED FOR ANOTHER HANDPIECE TO CONTINUE THE PROCEDURE. THERE WAS A DELAY OF ABOUT 10 MINUTES AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17642270 ↗
• MalfunctionJul 5, 2023Smoking; Device Damaged Prior to Use; Smoking; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THE FRONT BEZEL AND BACK COVERS WERE DAMAGED AND THERE WAS A BURNING SMELL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17258733 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT DURING GEN CHANGE OUT, THE REPRESENTATIVE STATED THEY EXPERIENCED PACING DOO, LOWER RATE (LR) 60, UNTIL PLASMA BLADE WAS USED. THE REPRESENTATIVE  STATED AFTER ~5SECONDS OF HANDPIECE USAGE, A PAUSE WAS NOTED, THE PATIENTS HEART RATE DROPPED BELOW THE PROGRAMMED LOWER RATE OF 60, AND THIS WAS NOTED ON PLETH MONITORING AS WELL.

  Patient problems: Bradycardia

  MAUDE report 16751357 ↗
• MalfunctionJan 4, 2023Device Damaged Prior to Use; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT THE SYSTEM WAS DROPPED AND THE PUMP WAS DAMAGED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095893 ↗
• MalfunctionJan 3, 2023Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT THE SYSTEM WOULD NOT REGISTER/READ THE BLADE PLUGGED INTO THE UNIT. UNIT SOUNDED LIKE IT HAD PIECED RATTLING AROUND INTERNALLY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16087973 ↗
• MalfunctionDec 19, 2022Peeled/Delaminated; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT THE COATING WAS PEELING OFF ON THE HANDPIECE. BILATERAL SKIN SPARING MASTECTOMY WAS THE PROCEDURE. THE DEVICE WENT BAD RIGHT AT THE VERY END OF THE PROCEDURE. THE SETTINGS WAS 6 CUT AND 10 COAG. THERE WAS NO IMPACT TO THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16004311 ↗
• MalfunctionAug 16, 2021Failure to Shut Off; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A GENERATOR. IT WAS REPORTED THAT THE MONOPOLAR PORT WAS CONTINUOUSLY ACTIVATING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12324301 ↗
• MalfunctionJul 12, 2021Failure to Shut Off; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A GENERATOR. IT WAS REPORTED THAT THEIR GENERATOR WAS CONSTANTLY PUMPING FLUID THROUGH HANDPIECES EVEN WHEN IT WAS NOT ACTIVATED. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12150601 ↗
• MalfunctionFeb 24, 2021Output above Specifications; Output above Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A GENERATOR. IT WAS REPORTED THAT DURING THE PREVENTATIVE MAINTENANCE (PM) THE GENERATOR FAILED ELECTRICAL SAFETY CHECK WITH HIGH LEAKAGE ON THE CASE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11373140 ↗
• MalfunctionFeb 24, 2021Fire; Fire

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT WHEN THEY WERE COMPLETING THE SYSTEM PREVENTATIVE MAINTENANCE (PM) WHILE DOING THE LOW POWER OUTPUT THERE WAS A SPARK AND A POP. THE SYSTEM OPERATIONAL FOR ALL OTHER OUTPUTS BUT LOW POWER WAS NO LONGER OPERATIONAL. THEY WERE ALSO RETURNING THE HANDPIECE AS WELL. THERE WAS A LITTLE BIT OF SCRAPPING ON THE END OF THE BLADE THAT WAS CAUSED BY THE CUSTOMER. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11372841 ↗
• MalfunctionJan 25, 2021Smoking; Smoking

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A GENERATOR. IT WAS REPORTED THAT THE FUSES WERE CHANGED ON THE SYSTEM AND THEN IT SMOKED. SYSTEM WILL NOT TURN ON. DISCOVERED OUTSIDE OF A CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11222892 ↗