AEXRecalls & reported problems across all models

We found 2 models of AEX by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between Apr 30, 2019 and Aug 18, 2026 — classified as 6 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Output above Specifications” (17 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 ™ 40-405-1

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  35 reports
• AEX ™ 40-405-1R

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  24 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.

• MalfunctionAug 18, 2026Output above Specifications

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50299234 ↗
• MalfunctionAug 4, 2026Use of Device Problem; Arcing of Electrodes

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50125607 ↗
• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT THE PHYSICIAN WAS USING CAUTERY DURING AN ICD EXPLANT AND FELT A SUDDEN BURN ON THE RIGHT ARM. THE PHYSICIAN¿S GOWN WAS BURNED. IT WAS REPORTED THAT THE GROUNDING PAD OR AN ACCESSORY MAY HAVE CAUSED THE ISSUE. THE ISSUE OCCURRED INTRAOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE OCCURRED DURING ICD IMPLANT AND THE INJURY TO THE PHYSICIAN WAS MINOR. THERE WAS NO IMPACT TO THE PATIENT OUTCOME. THERE WAS A DELAY OF LESS THAN 30 MINS TO THE PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 25598473 ↗
• MalfunctionFeb 4, 2026Output above Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) ON THE GENERATOR, BIPOLAR OUTPUT FAILURE OCCURRED, WITH THE GENERATOR UNABLE TO PRODUCE WATTAGE WITHIN TOLERANCE AND OUTPUT WATTAGE MEASURED AT MORE THAN DOUBLE THE MAXIMUM TOLERANCE DURING TESTING. IMPEDANCE MEASUREMENT WAS 100 OHMS, WATTAGE MEASUREMENT WAS 110 WATTS, AND OUTPUT MEASUREMENT WAS 280 WATTS, WITH OTHER SIMILAR TESTS CONFIRMING THE OUTPUT ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257238 ↗
• MalfunctionJun 4, 2025Fire; Fire

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THE GENERATOR CONSOLE WAS SPARKING I NTERNALLY DURING PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22142392 ↗
• MalfunctionMay 28, 2025Output above Specifications; Output above Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT A PORTION OF THE GENERATOR FAILED AS CUTS 1, 2, 3, AND 5 WERE NOT WITHIN RANGE. ANOTHER GENERATOR WAS USED, AND IT WAS ABLE TO GET CUTS 1-5 TO PASS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094267 ↗
• MalfunctionMar 4, 2025Output above Specifications; Output below Specifications; Output above Specifications; Output below Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT WHEN SITE PERFORMED PM ON A GENERATOR, THERE WAS A FAILURE ON THE LOW WATTAGE SIDE. ADDITIONALLY, WHEN TESTING CUT 1, THE RESULTS WERE EXTREMELY HIGH, TESTING AT 100 FOR TOLERANCE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21511735 ↗
• MalfunctionFeb 10, 2025Melted; Melted

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT DURING A HIP REVISION SURGERY, THE PLASTIC ON THE HANDPIECE WAS MELTED. THE HANDPIECE WAS USED AGAINST METAL, SUCH AS A HEMOSTAT, WHICH WAS LIKELY THE CAUSE OF THE MELTING. ONCE THE ISSUE OCCURRED, THE SURGICAL TEAM SWITCHED TO USING A OTHER HANDPIECE. THE INCIDENT HAPPENED TOWARDS THE END OF THE PROCEDURE, WHICH LASTED ALMOST FOUR HOURS. THERE WAS A SURGICAL DELAY OF LESS THAN ONE HOUR AND WAS NO REPORTED IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343242 ↗
• MalfunctionJan 29, 2025Fire; Fire

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THERE WAS A BURNING SMELL FROM GENER ATOR. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21262904 ↗
• MalfunctionDec 30, 2024Electromagnetic Interference; Electromagnetic Interference

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS PACEMAKER GENERATOR CHANGE AND THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035421 ↗
• MalfunctionNov 6, 2024Failure to Power Up; Smoking; Failure to Power Up; Smoking

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THE SYSTEM WAS NOT POWERING UP. REPORTED A STRONG BURNT SMELL AND ONE OF THE BOARDS INSIDE THE UNIT WAS HEAVILY SCORCHED. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20618912 ↗
• MalfunctionOct 18, 2024Fire; Fire

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROCEDURE PERFORMED DURING THE EVENT WAS SPINE CASE AND THERE WAS A MINIMAL DELAY IN SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20479498 ↗
• MalfunctionOct 16, 2024Electromagnetic Interference; Electromagnetic Interference

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT THE SITE HAD A GENERATOR THAT WHEN ACTIVATED CAUSED THE EKG MACHINE NEARBY TO STOP WORKING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20462487 ↗
• MalfunctionJun 11, 2024Output above Specifications; Output above Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT WHILE PERFORMING THE PREVENTATIVE MA INTENANCE (PM) ON THE SYSTEM, SEVERAL OF THE VOLTAGES THE SITE WERE MEASURING WERE SIGNIFICANTLY HIGHER THAN THEY SHOULD BE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19508123 ↗
• InjuryMar 12, 2024Electromagnetic Interference; Electromagnetic Interference

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR AND HANDPIECE. IT WAS REPORTED THAT WHEN THE SURGEON WENT TO CUT A POCKET USING A HANDPIECE ON THIS GENERATOR, THE PACER DEPENDENT PATIENT WENT ASYSTOLIC FOR 20 SECOND PRIOR TO BEING HOOKED UP TO A MEDTRONIC PROGRAMMER. OTHERWISE, THERE WERE NO PATIENT ISSUES.

  Patient problems: Cardiac Arrest

  MAUDE report 18888246 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls