AEXRecalls & reported problems across all models

We found 2 models of AEX by Medtronic Navigation, Inc. in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Sep 10, 2020 and Sep 2, 2026 — classified as 3 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Output above Specifications” (15 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

Most reported AEX problems

AEX models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AEX™ 40-405-1R

  Electrosurgical, cutting & coagulation & accessories
  37 reports
• AEX™ 40-405-1

  Electrosurgical, cutting & coagulation & accessories
  11 reports

Recent AEX adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Fire

  Information was received from a manufacturer representative regarding a generator. It was reported that the generator shorted out. The issue occurred intraoperatively but there was no reported impact on the patient outcome.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50570413 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem; Activation Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT DURING A CARDIAC HEART TRANSPLANT PROCEDURE, A THERMAL INJURY/BURN WAS IDENTIFIED ON THE PATIENT¿S LOWER LEFT ABDOMEN DURING THE POST-OPERATIVE SKIN ASSESSMENT. THE TEAM ESCALATED APPROPRIATELY AND THE PATIENT WAS HELD FOR A PLASTIC SURGERY CONSULTATION PRIOR TO TRANSFER TO THE INTENSIVE CARE UNIT. THE BIPOLAR HANDPIECE WAS DISPOSED OF BY THE SITE AND WAS NOT RETURNED. THE ISSUE OCCURRED INTRA-OPERATIVELY AND PATIENT WAS AFFECTED.

  Patient problems: Burn(s)

  MAUDE report 24869324 ↗
• MalfunctionApr 6, 2026Fire

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR AND HANDPIECE. IT WAS REPORTED THAT, DURING SURGERY, A HANDPIECE PRODUCED SPARKS, AND SPARKS WERE ALSO OBSERVED COMING OUT OF THE GENERATOR. THE ISSUE OCCURRED INTRA-OPERATIVELY, PATIENT WAS INVOLVED BUT NO REPORTED IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24796238 ↗
• MalfunctionMar 17, 2026Output above Specifications; No Device Output; Failure of Device to Self-Test

  MEDTRONIC RECEIVED INFORMATION REGARDING A GENERATOR BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHILE PERFORMING AN ELECTRICAL SAFETY TEST, THE GROUND PRODUCED .344, WELL ABOVE THE TOLERANCE OF .2. SITE TRIED MULTIPLE POWER CABLES BUT THE ISSUE PERSISTED. ERROR MESSAGE WAS ALSO REPORTED AND FAILING ELECTRICAL SAFETY TEST. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24614330 ↗
• MalfunctionJan 28, 2026Premature Activation; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED. IT WAS REPORTED THAT THERE WAS NO MALFUNCTION ASSOCIATED WITH THE GENERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199827 ↗
• MalfunctionNov 20, 2025Failure to Shut Off; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT DURING PROCEDURE, THERE WAS NO OR INSUFFICIENT BIPOLAR ENERGY IDENTIFIED WITH THE GENERATOR. THERE WAS NO REPORTED IMPACT ON PATIENT. 2025-OCT-29 E1 (REP): ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SURGEON WOULD ACTIVATE THE DEVICE (BY PRESSING THE CUT OR COAG BUTTON) BUT IT WOULD NOT DEACTIVATE WHEN HER FINGER CAME OFF THE BUTTON. THE DEVICE WAS STILL ACTIVATED EVEN THOUGH SHE WAS NOT PRESSING THE BUTTON AT ALL. IT WOULD REMAIN UNTIL SHE GROUNDED IT ON THE PATIENT OR OTHER OBJECT. THE PROBLEM OCCURRED INTRA-OPERATIVELY DURING BREAST SURGERY (MASTECTOMY) AND THERE WAS NO IMPACT TO PATIENT. ISSUE CAUSED MINOR DELAYS OF LESS THAN AN HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23603901 ↗
• MalfunctionNov 13, 2025No Device Output; Failure to Shut Off; No Device Output; Failure to Shut Off

  IT WAS REPORTED THAT DURING A PROCEDURE THE GENERATOR DISPLAYED ERROR F9 DURING USE. SITE REPORTED THAT THE HANDPIECE CONTINUED TO FIRE WHEN THE BUTTON WAS NOT BEING PRESSED. THEY USED ANOTHER SYSTEM TO PROCEED AND WAS UNABLE TO REPLICATE ISSUE AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543832 ↗
• MalfunctionOct 26, 2025Fire; Device Damaged Prior to Use; Fire; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THE GENERATOR WAS DROPPED WHILE BEING MOVED, RESULTING IN DAMAGE TO THE GENERATOR CASE AND A REPORT THAT IT SUPPOSEDLY SPARKED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23387858 ↗
• MalfunctionMay 26, 2025No Device Output; Arcing of Electrodes; No Device Output; Arcing of Electrodes

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT A REPLACEMENT UNIT WAS SHIPPED AND FAILED ITS ELECTRICAL SAFETY DUE TO A SEVERE GROUND FAULT WHEN BEING POWERED ON, CAUSING CURRENT TO BE PUSHED OUT OF THE CHASSIS GROUND. THE DEVICE WAS NEVER PLACED INTO SERVICE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084662 ↗
• MalfunctionApr 25, 2025Failure to Shut Off; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT DURING PROCEDURE, THE GENERATOR CONTINUED TO PROVIDE POWER TO THE HANDPIECE DESPITE ATTEMPTS TO DEPRESS THE COAGULATION BUTTON, INDICATING AN INABILITY TO TURN OFF COAGULATION. THE ISSUE PERSISTED EVEN AFTER ANOTHER HANDPIECE WAS OPENED. THE PROBLEM WAS RESOLVED BY BRINGING IN ANOTHER GENERATOR. THERE WAS A SURGICAL DELAY OF LESS THAN 1 HOUR AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21906899 ↗
• MalfunctionMar 20, 2025Fire; Device Damaged Prior to Use; Intermittent Energy Output; Fire; Device Damaged Prior to Use; Intermittent Energy Output

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT A GENERATOR WAS EXPERIENCING ISSUES, SPECIFICALLY SHORTING OUT WHENEVER A HANDPIECE WAS PLUGGED IN. ADDITIONALLY, IT WAS OBSERVED THAT THE UNIT APPEARED TO HAVE BEEN DR OPPED, RESULTING IN PHYSICAL DAMAGE AND CAUSING IT TO WORK INTERMITTENTLY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651411 ↗
• MalfunctionFeb 25, 2025Energy Output Problem; Output above Specifications; Output below Specifications; Energy Output Problem; Output above Specifications; Output below Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, A GEN ERATOR HAD FAILED THE CUT TEST AND HAD SHOWN THE VALUES THAT WERE NOT EXPECTED. THE CUT OUTPUT ISSUE WAS IDENTIFIED, WHERE THE DEVICE, WHEN SET FOR 2 WATTS, HAD ONLY OUTPUTTED LOW VALUE 0.8 WATTS, AND WHEN SET FOR 8 WATTS, IT HAD OUTPUTTED THE HIGHER VALUE OVER 49 WATTS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21455918 ↗
• MalfunctionNov 26, 2024Output above Specifications; Output above Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT WHILE PERFORMING A PM WITH THE HANDPIECE, CUT 4-5 HAD TOLERANCES ABOVE SPECIFICATIONS. CUT 4 WAS APPROXIMATELY 7, CUT 5 WAS 13. AND CUT 3 WAS 3.9. ALL OTHER CUTS WERE WITHIN THE TOLERANCES. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20783649 ↗
• MalfunctionJul 5, 2024Output above Specifications; Failure to Shut Off; Output above Specifications; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THA T DURING TWO CASES A GENERATOR WAS USED AND EXCESS POWER WAS DELIVERED TO TWO SEPARATE HANDPIECES AND MAY HAVE RESULTED IN HARM TO THE PATIENTS. THE COAG FUNCTION WAS GETTING "STUCK"; IT STAYED ACTIVE AND DELIVERED POWER EVEN AFTER IT WAS LET GO. THERE WAS NO DELAY OR PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT ONE PATIENT WAS BURNED CLOSE TO THE INCISION AND THE ISSUE OCCURRED DURING A BREAST LUMPECTOMY WITH SENTINEL NODES PROCEDURE AND A EXCISIONAL BIOPSY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19681194 ↗
• MalfunctionJun 7, 2024Overheating of Device; Failure to Shut Off; Overheating of Device; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT THE GENERATOR WOULD GET HOT AND WOULDN'T TURN OFF WHEN POWER BUTTON WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19488095 ↗

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