CardioMessenger Smart 3GRecalls & reported problems
BIOTRONIK SE & Co. KG · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04035479139360), received between Feb 26, 2021 and Dec 10, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (4 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
Device problems
- Overheating of Device4
- Electrical /Electronic Property Problem1
- Smoking1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2021Electrical /Electronic Property Problem; Overheating of Device; Smoking; Electrical /Electronic Property Problem; Overheating of Device; Smoking
THE POWERCORD WAS SMOKING AND BURNT. REQUEST RETURN DEVICE AND POWER CORD. 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 12979604 ↗MalfunctionNov 9, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE PATIENT NOTICED A BURNING SMELL; THE MONITOR WAS SCORCHED AT PLUG IN SITE, POWER CORD BURNT AND MONITOR BLACKENED WITH DAMAGE. PATIENT DISABLED THE UNIT IMMEDIATELY. 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 12781591 ↗MalfunctionAug 18, 2021Overheating of Device; Overheating of Device
THIS CARDIOMESSENGER OVERHEATED AND CAUGHT ON FIRE. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12339848 ↗MalfunctionFeb 26, 2021Overheating of Device; Overheating of Device
THIS CARDIOMESSENGER IS OUT OF SERVICE DUE TO POWER CORD BURNED UP. 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 11388692 ↗
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- Medtronic CareLink® Programmer 2090AA4Medtronic, Inc. · Pacemaker/icd/crt non-implanted components3 recalls82 reports
- Entrant™ CDDRA300QSt. Jude Medical, Inc. · Pacemaker/icd/crt non-implanted components1 recall2 deaths158 reports
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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