CardioMessenger Smart 4G US mit WW Modem 470662Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04035479177768), received between Aug 22, 2024 and Jun 22, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Melted” (2 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.
Reports received per month
Most reported problems
Device problems
- Melted2
- Overheating of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 22, 2026Melted
THIS CARDIOMESSENGER APPEARS TO HAVE CAUGHT ON FIRE AND MELTED. NO DETAILS ARE KNOW AT THIS TIME BUT COMPLAINT WILL BE UPDATED WHEN THEY BECOME AVAILABLE. NO ADVERSE PATIENT EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25576800 ↗MalfunctionApr 17, 2026Melted
THE CARDIO MESSENGER HAS SOME MELTING DAMAGE ON IT WHERE THE POWER CORD GOES INTO THE CM PER PTS SISTER. 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 24915962 ↗MalfunctionAug 22, 2024Overheating of Device; Overheating of Device
CORD STARTED SMOKING AND MELTED INTO THE DEVICE. NO KNOWN ISSUES WITH POWER OUTLET. 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 20030240 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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