C6 Monitor A13, Verizon 02-02386Recalls & reported problems

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838128729), received between Jul 7, 2026 and Jul 7, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Melted” (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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Melted1
Overheating of Device1

Patient problems

Superficial (First Degree) Burn1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 7, 2026Melted; Overheating of Device
IT WAS REPORTED THAT ON (B)(6) 2026, THAT THE MCOT MONITOR - A13 - VERIZON WAS GETTING HOT TO THE TOUCH WHOLE CHARGING. THE PATIENT'S DAUGHTER TOUCHED THE MONITOR AND BURNED THEIR FINGER ON THE BASE OF THE MONITOR AND MONITOR CHARGING CABLE. IT WAS ALSO NOTED THAT THE MONITOR AND CHARGING CORD HAD BURN MARKS. NO MEDICAL ATTENTION WAS SOUGHT FOR THE BURN. THERE WAS NO PROPERTY DAMAGE. A REPLACEMENT WAS ORDERED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Superficial (First Degree) Burn
MAUDE report 25735478 ↗

Device details

UDI-DI	`00884838128729`
Brand	C6 Monitor A13, Verizon
Model	02-02386
Company	Braemar Manufacturing, LLC
Product code	DSI · Detector And Alarm, Arrhythmia
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 25, 2026

Device type (GMDN): Electrocardiographic ambulatory recorder

An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).

Other Detector And Alarm, Arrhythmia devices

Reveal LINQ™ LNQ11
Medtronic, Inc. · DETECTOR AND ALARM, ARRHYTHMIA
1 recall7,581 reports
Confirm Rx™ DM3500
St. Jude Medical, Inc. · DETECTOR AND ALARM, ARRHYTHMIA
2 recalls2 deaths5,149 reports
Reveal LINQ TM LNQ11
Medtronic, Inc. · DETECTOR AND ALARM, ARRHYTHMIA
1 death1,592 reports
Jot Dx™ DM4500
St. Jude Medical, Inc. · DETECTOR AND ALARM, ARRHYTHMIA
1 death1,005 reports
Reveal LINQ™ LNQ11
Medtronic, Inc. · DETECTOR AND ALARM, ARRHYTHMIA
1 death930 reports
LINQ II™ LNQ22
Medtronic, Inc. · DETECTOR AND ALARM, ARRHYTHMIA
2 recalls673 reports
Reveal LINQ™ LNQ11
Medtronic, Inc. · DETECTOR AND ALARM, ARRHYTHMIA
431 reports
Reveal LINQ™ LNQ11
Medtronic, Inc. · DETECTOR AND ALARM, ARRHYTHMIA
1 recall343 reports

All Detector And Alarm, Arrhythmia devices →

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.

How reports and recalls are matched · Editorial policy · Report an error on this page