AEX™ 40-405-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000281007), received between Oct 30, 2020 and Sep 2, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Output above Specifications” (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. 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 11 most recent of 11 reports, 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 ↗
• 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 ↗
• MalfunctionJun 7, 2024Fire; Fire

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THA T WHILE ASSISTING ON A CASE, THE HANDPIECE STARTED SPARKING AND TEMPORARILY CREATED A SHORT ON THE LEAD. THE SITE FINISHED UP THE CASE WITH THE INSTRUMENT. THERE WAS A DELAY OF LESS THAN 1 HOUR AND NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PHYSICIAN ASSUMED HE TOUCHED THE HANDPIECE TO THE CLIPS ON THE PACING CABLES CAUSING THE SPARK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19482628 ↗
• MalfunctionOct 27, 2023Electromagnetic Interference; Electromagnetic Interference

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED "THAT" DURING SURGERY FOR A PACEMAKER BATTERY DEVICE CHANGEOUT, AS SOON AS THE GENERATOR WAS CONNECTED TO THE PATIENT GROUNDING PAD, NO HANDPIECE PLUGGED IN, THE PATIENT SINUS RHYTHM ON THE NON-MEDTRONIC EKG MONITOR WERE IRREGULAR AND INTERRUPTED. PATIENT WAS NOT HARMED AND SURGERY CONTINUED. THERE WAS NO DELAY. TROUBLESHOOTING WAS PERFORMED. THE GROUNDING PAD WAS REPLACED, THE SYSTEM REBOOTED AND THEY MOVED TO DIFFERENT OUTLETS. WHEN THEY TESTED THE SYSTEM AFTER SURGERY OUTSIDE OF THE OR THE ISSUE WAS ABLE TO BE REPLICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18022883 ↗
• MalfunctionOct 23, 2023Output above Specifications; Output above Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THE SITE WAS TRYING TO COMPLETE THE ACCEPTANCE TEST AND THEY TOOK THE TESTING UNIT AND THE IMPEDANCE VALUES OF WHAT THEY SHOULD GET. THEY TESTED THE OUTPUTS FOR THE BIPOLAR AND THEY PASSED. THEY THEN TRIED TESTING THE OUTPUTS FOR THE MONOPOLAR AND CUT 1-5 WERE OFF. THEY TESTED THE RECOMMENDED CUT 8 AND 10 AND THEY WERE WITHIN RANGE. THEY THEN TESTED COAG 5 AND COAG 8. COAG 5 WAS HIGHER THAN EXPECTED. IT WAS CONFIRMED THE SETUP FOR TESTING AND THAT IT WAS CLAMPED ON TO ONLY THE EDGE OF THE PROBE AND WAS CONSISTENTLY GETTING HIGHER THAN EXPECTED VALUES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17988442 ↗
• MalfunctionSep 27, 2023Output above Specifications; Output above Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THE GENERATOR WAS FAILING MULTIPLE RF OUTPUT TEST POINTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17826081 ↗
• MalfunctionJun 17, 2022Output above Specifications; Output above Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THE SYSTEM WAS OUT OF SPEC FOR PREVENTATIVE MAINTENANCE (PM). HIGH OUTPUT FOR CO-AG SETTINGS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14739646 ↗
• MalfunctionJan 7, 2022No Device Output; Smoking; No Device Output; Smoking

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT THERE WAS AN F9 ERROR CODE AND THE UNIT HAD A BURNING SMELL WHEN IN USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13192544 ↗
• MalfunctionJul 22, 2021Output above Specifications; Output below Specifications; Output above Specifications; Output below Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A GENERATOR. IT WAS REPORTED THAT THE SYSTEM WAS OUT OF TOLERANCE DURING PREVENTATIVE MAINTENANCE (PM). THE ISSUE WAS WITH THE MONOPOLAR PORT ONLY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211797 ↗
• MalfunctionOct 30, 2020Output above Specifications; Output above Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A GENERATOR. IT WAS REPORTED THAT THE LEAKAGE OF THE UNIT WAS .62 OHMS WHICH WAS MUCH HIGHER THAN THE 0.1 RECOMMENDED. THERE WAS NO PATIENT INVOLVEMENT AND THE HCP WAS TRANSFERRED TO SERVICE AND REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10763073 ↗