AEXTMRecalls & reported problems across all models
Medtronic, Inc. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 2 models of AEXTM by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Apr 15, 2019 and Aug 27, 2026 — classified as 3 injuries, 28 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. 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 AEXTM problems
Device problems
- Failure to Shut Off6
- Electromagnetic Interference5
- Output above Specifications5
- Activation Problem4
- Adverse Event Without Identified Device or Use Problem2
- Arcing of Electrodes2
- Device Damaged Prior to Use2
- Fire2
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Consequences Or Impact To Patient2
- Atrial Tachycardia1
- Bradycardia1
- Burn(s)1
- Tachycardia1
AEXTM models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AEXTM 40-405-1ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES29 reports
- AEXTM 40-405-1ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
Recent AEXTM adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Medtronic, Inc. products
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- SYNCHROMED II11 models · 32,260 reports · 4 recalls
- CAPSUREFIX NOVUS17 models · 27,547 reports
- INTERSTIM30 models · 24,415 reports · 1 recall
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- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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