AEXTM 40-405-1 (UDI 00643169427013)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169427013), received between Aug 19, 2020 and Sep 1, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Arcing of Electrodes” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2022Arcing of Electrodes; Noise, Audible; Arcing of Electrodes; Noise, Audible

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT THE UNIT WAS ARCING AND HAD HUMMING NOISE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15337228 ↗
• InjuryAug 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A GENERATOR AND HANDPIECE BEING USED FOR PACEMAKER IMPLANTATION. IT WAS REPORTED THAT ALCOHOLIC ANTISEPTIC WAS USED DURING PROCEDURE ON THE PATIENT'S SKIN WHICH WAS NOT ALLOWED ACCORDING TO THE IFU. THE PATIENT'S SKIN WHERE THE ALCOHOLIC ANTISEPTIC WAS STILL PRESENT GOT BURNT WHEN THE HANDPIECE WAS PUT INTO OPERATION. IT WAS NOTED THAT THE PROCEDURE COULD NOT BE PERFORMED WITH THE HANDPIECE AS THE DEVICE BURNT THE PATIENT. THE PROCEDURE WAS ABORTED AND POSTPONED. IT WAS NOTED THAT THERE WAS NO PERMANENT INJURY AND ONLY ERTHYTHEMA ON THE SKINS SURFACE WHERE IT MET THE HANDPIECE. THERE WAS NO MEDICAL INTERVENTION NEEDED.

  Patient problems: Burn(s)

  MAUDE report 10429176 ↗