MyCareLink™ 24950M (UDI 00763000367800)Recalls & reported problems

Medtronic, Inc. · MON 24950M MYCARELINK/SVC USA · Class 3

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Quick summary

This is a Medtronic MyCareLink remote monitor, the home unit that relays information from an implanted heart device. The 65 reports mostly describe the monitor overheating; a few mention a burning smell, brown residue oozing from the unit, moisture getting inside, or delivered stimulation not matching what was set. Reports also note four burns and one allergic reaction, and most describe no lasting patient effect. No deaths and no injuries are reported. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 65
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00763000367800), received between Aug 25, 2020 and Jul 24, 2025 — classified as 65 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (56 reports).

10 other recalls cover devices cleared under the same FDA submission (P890003); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Overheating of Device56
Device Emits Odor4
Inappropriate/Inadequate Shock/Stimulation3
Moisture Damage2
Use of Device Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions59
No Consequences Or Impact To Patient5
Burn(s)4
Hypersensitivity/Allergic reaction1

Recent adverse event reports

The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 24, 2025Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22587373 ↗
MalfunctionDec 5, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS OVERHEATING. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20853943 ↗
MalfunctionNov 22, 2023Moisture Damage; Moisture Damage
IT WAS REPORTED THAT THERE WAS A "BROWN STUFF" OOZING OUT OF THE MONITOR. NO TROUBLESHOOTING TAKEN. THE MONITOR IS EXPECTED TO BE RE PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18190353 ↗
MalfunctionJun 14, 2023Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17126129 ↗
MalfunctionApr 12, 2023Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16722755 ↗
MalfunctionMar 9, 2023Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16513094 ↗
MalfunctionMar 6, 2023Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16484780 ↗
MalfunctionFeb 23, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16428127 ↗
MalfunctionDec 28, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS HOT LIKE BURNING. NO TROUBLESHOOTING TAKEN AT THE TIME OF CALL. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16060636 ↗
MalfunctionDec 22, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE MONITOR GOT REALLY HOT AND THE READER WAS SO HOT THAT THE PATIENT COULD NOT HOLD ON TO IT. THE PATIENT STATED THAT EVERYTHING WAS CHECKED OUT AND THE MONITOR WAS STILL ACTING UP. THE MONITOR WAS TOTALLY UNPLUGGED FOR SAFETY'S SAKE. NO FURTHER TROUBLESHOOTING PERFORMED. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16037873 ↗
MalfunctionNov 21, 2022Moisture Damage; Moisture Damage
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15834721 ↗
MalfunctionNov 18, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR BECAME HOT TO TOUCH THAT IT WAS REMOVED FROM THE PATIENT'S HOUSE FOR FEAR OF STARTING A FIRE. NO TROUBLESHOOTING WAS TAKEN AT THE TIME OF CALL. IT WAS STATED THAT THE MONITOR HAD BEEN DISCARDED. THE REMOTE MONITOR REPLACEMENT STATUS IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15824265 ↗
MalfunctionOct 11, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. THE PATIENT UNPLUGGED THE MONITOR FROM THE POWER SUPPLY. NO FURTHER TR OUBLESHOOTING PERFORMED AT THE TIME OF CALL. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15579330 ↗
MalfunctionSep 19, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. NO TROUBLESHOOTING TAKEN. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15445111 ↗
MalfunctionSep 8, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. THE REMOTE MONITOR WAS UNPLUGGED. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15378521 ↗
MalfunctionAug 16, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE READER WAS TOO HOT TO TOUCH. NO TROUBLESHOOTING TAKEN. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15237291 ↗
MalfunctionAug 16, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. NO TROUBLESHOOTING WAS TAKEN. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15237153 ↗
MalfunctionJul 7, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR STARTED TO BURN AFTER PLUGGING IT. IT WAS FURTHER REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. NO TROUBLESHOOTING WAS TAKEN. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14950003 ↗
MalfunctionMay 23, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT. THE PATIENT WAS INFORMED TO UNPLUG THE MONITOR. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14472421 ↗
MalfunctionMay 13, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS OVERHEATING. THE PATIENT WAS ADVISED TO UNPLUG THE MONITOR AND NO FURTHER TROUBLESHOOTING WAS INDICATED. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14399406 ↗
MalfunctionMay 7, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE THE READER WAS GETTING TOO HOT TO TOUCH. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14315521 ↗
MalfunctionApr 24, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE PATIENT SAW SPARKS COMING FROM THE REMOTE MONITOR SCREEN. THE MONITOR WAS ALREADY UNPLUGGED. NO FURTHER TROUBLESHOOTING TAKEN. THE REMOTE MONITOR IS EXPECTED TO BE RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14191222 ↗
MalfunctionApr 18, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR READER WAS HOT TO THE CHEST AND BURNED THE PATIENT. NO TROUBLESHOOTING INDICATED. THE MONITOR REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Burn(s)
MAUDE report 14137723 ↗
MalfunctionApr 14, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. NO TROUBLESHOOTING INDICATED. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14114196 ↗
MalfunctionApr 14, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT. NO TROUBLESHOOTING INDICATED. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14114166 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P890003. One submission often covers many models, so check the product and lot details in each record.

Z-2168-2025 · Jun 18, 2025 · Open, Classified
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria
Z-2169-2025 · Jun 18, 2025 · Open, Classified
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria A
Z-2128-2025 · Jun 17, 2025 · Open, Classified
Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model N
Z-2127-2025 · Jun 17, 2025 · Open, Classified
Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D
Z-2505-2020 · Jun 4, 2020 · Open, Classified
CareLink SmartSync Device Manager, Model Number 24970A
Z-2506-2020 · Jun 4, 2020 · Open, Classified
Patient Connector, Model Number 24967
Z-0845-2019 · Jan 17, 2019 · Terminated
Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
Z-0399-2018 · Jul 14, 2017 · Terminated
MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with
Z-0400-2018 · Jul 14, 2017 · Terminated
MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic device that communicates
Z-2209-2010 · Jun 11, 2010 · Terminated
Medtronic Carelink Monitor Model 2490C. The Medtronic CareLink Monitor Model 2490C is designed to automatically gather information from the implanted heart device. This automatic w

Device details

UDI-DI	`00763000367800`
Brand	MyCareLink™
Model	24950M
Company	Medtronic, Inc.
Product code	NVZ · Pulse generator, permanent, implantable
Class	Class 3
FDA submission	P890003
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	Jun 19, 2020

Device type (GMDN): Cardiac pulse generator reader, home-use

An external device intended to enable a layperson to noninvasively extract data from an implanted cardiac pulse generator (i.e., therapeutic active cardiac implant) to provide historic and/or current information on device performance, and may in addition be intended to communicate with a diagnostic cardiac implant (e.g., implantable cardiac monitor); it is not intended to program therapeutic implants and is dedicated to cardiac use. It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software. This is a home-use device.

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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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 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