CardioMessenger Smart 4G US 438613Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04035479159115), received between Oct 7, 2020 and Oct 10, 2024 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (13 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 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionOct 10, 2024Overheating of Device; Overheating of Device

  PATIENT SAID SHE TOOK CARDIO MESSENGER ON VACATION AND IT LOOKS LIKE IT EXPLODED IN HER BAG. THE PARTS ARE SEPARATED SOME AND ITS WARPED. PATIENT SAID IT WAS NOT LEFT IN A CAR AND IT LOOKS LIKE IT OVERHEATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20416172 ↗
• MalfunctionMar 1, 2022Overheating of Device; Overheating of Device

  PATIENT SAYS THE HOUSING OF THE MONITOR IS SWOLLEN, LIKE HEAT HAS MADE IT EXPAND. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13638774 ↗
• MalfunctionFeb 24, 2022Overheating of Device; Overheating of Device

  THE CARDIO MESSENGER WAS GETTING VERY HOT WHILE CHARGING. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595637 ↗
• MalfunctionFeb 24, 2022Overheating of Device; Overheating of Device

  THE CARDIO MESSENGERS CORD HAD MELTED INTO THE MONITOR AND WAS NO LONGER WORKING. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595634 ↗
• MalfunctionJan 19, 2022Overheating of Device; Overheating of Device

  PATIENT REPORTED THAT THIS MONITOR HAS SCORCH MARKS ON IT LIKE ITS OVERHEATING. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13288753 ↗
• MalfunctionDec 21, 2021Electrical /Electronic Property Problem; Overheating of Device; Smoking; Electrical /Electronic Property Problem; Overheating of Device; Smoking

  CM GOT BURNT FROM POWER CORD AND WAS DISPOSED OF. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13056436 ↗
• MalfunctionDec 6, 2021Melted; Melted

  WHILE PLUGGED INTO A POWER SOURCE, THE POWER CORD MELTED INTO THE CARDIOMESSENGER PORTAL AND MELTED. THEY ATTEMPTED TO PULL THE POWER CORD OUT OF THE PORTAL AND INTERIOR METAL WAS ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12934672 ↗
• MalfunctionOct 15, 2021Overheating of Device; Overheating of Device

  CARDIOMESSENGER PORT HAS SCORCH MARKS WITH SLIGHT MELTING BUT IS STILL ABLE TO CONNECT TO CELL TOWER. PATIENT IS NOT COMPLIANT FOR USE OF CARDIOMESSENGER. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12641015 ↗
• MalfunctionSep 28, 2021Overheating of Device; Overheating of Device

  THIS CARDIOMESSENGER WAS RETURNED. WHERE THE POWER CORD CONNECTS TO THE DEVICE, IT IS BURNT. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541235 ↗
• MalfunctionSep 15, 2021Overheating of Device; Overheating of Device

  PATIENT SAYS DEVICE AND CHARGER BECAME HOT AND THE PORT IS BURNED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474403 ↗
• MalfunctionAug 12, 2021Overheating of Device; Overheating of Device

  THIS CARDIOMESSENGER SHOWS SIGNS OF BURNS. IT IS UNCLEAR IF IT WAS DUE TO A POWER SURGE OR RANDOM ISSUE THAT CAUSED THE CHARGER TO BURN. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12313574 ↗
• MalfunctionMay 27, 2021Overheating of Device; Overheating of Device

  THIS CARDIO MESSENGER WAS RETURNED TO BIOTRONIK WITHOUT A WRITTEN COMPLAINT. THE DEVICE APPEARS TO HAVE BURN MARKS WHERE THE POWER CORD ATTACHES TO THE UNIT. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11898579 ↗
• MalfunctionApr 29, 2021Overheating of Device; Overheating of Device

  PATIENTS DAUGHTER CALLED TO REPORT THAT THE UNIT HAD OVERHEATED AND THE WIRE HAD MELTED. WAS INSTRUCTED TO UNPLUG IMMEDIATELY. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11744742 ↗
• MalfunctionApr 6, 2021Overheating of Device; Overheating of Device

  A CARDIOMESSENGER SMART 4G WAS RETURNED AND IT IS BURNT AT THE POWER CONNECTION. THE POWER CORD IS ALSO BURNED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11621919 ↗
• MalfunctionOct 7, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  DEVICE WAS TRANSMITTING JUST FINE THEN ON (B)(6) 2020 THE PATIENT FELT A PAINFUL SHOCK GO THROUGH HER HAND WHEN SHE TOUCHED THE CARDIO MESSENGER AND THEN THE DEVICE WOULD NO LONGER POWER ON.

  Patient problems: Electric Shock

  MAUDE report 10642323 ↗