MyCareLink™ 24950L (UDI 00763000033194)Recalls & reported problems

Medtronic, Inc. · MON 24950L USA MKT M10.2 USA · Class 3

All models of MyCareLink (33)

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

Quick summary

This Medtronic MyCareLink 24950L remote monitor is the home unit that relays data from an implanted heart device. Reports mostly describe the monitor or its power cord overheating, sometimes hot enough to damage a wall outlet or swell a battery; a few mention unwanted shocks or stimulation. There are 32 reports, with no deaths and no injuries. 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: 32
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00763000033194), received between Mar 24, 2020 and Aug 27, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (29 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. 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

Overheating of Device29
Inappropriate/Inadequate Shock/Stimulation2
Mechanical Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions27
No Consequences Or Impact To Patient6
Burn(s)1
No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 27, 2026Overheating of Device
It was reported that the MyCareLink remote monitor was overheating. The patient unplugged the monitor. No troubleshooting indicated. Replacement monitor was ordered. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50474515 ↗
MalfunctionNov 3, 2025Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23452078 ↗
MalfunctionApr 1, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT A REMOTE MONITOR WAS OVERHEATING. THE CALL PROCEEDED WITHOUT TROUBLESHOOTING AND THE PATIENT WAS INSTRUCTED TO RETURN THE MONITOR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21739422 ↗
MalfunctionJul 24, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19816161 ↗
MalfunctionJun 8, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS OVERHEATING. THE PATIENT DISCONNECTED THE MONITOR. NO FURTHER TROUBLESHOOTING WAS 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 17091044 ↗
MalfunctionMay 25, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE BATTERY OF THE REMOTE MONITOR BLEW UP. NO TROUBLESHOOTING TAKEN AS THE PATIENT NO LONGER HAD ANY MONITOR. THE 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 17001006 ↗
MalfunctionApr 7, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE POWER CORD OF THE REMOTE MONITOR THAT WAS PLUGGED INTO THE OUTLET OVERHEATED AND RUINED THE POWER OUTLET. 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 16703114 ↗
MalfunctionMar 24, 2023Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16612504 ↗
MalfunctionFeb 17, 2023Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16395219 ↗
MalfunctionDec 22, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT WHEN THE PATIENT TRIED TO PICK UP THE REMOTE MONITOR READER AND PLACED OVER THE HEART IT WAS TOO HOT TO TOUCH. THE PATIENT PLACED ON THE MONITOR BASE AND TRIED AGAIN LATER BUT WAS STILL HOT. NO FURTHER TROUBLESHOOTING 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 16037837 ↗
MalfunctionNov 4, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. THE PATIENT UNPLUGGED THE REMOTE MONITOR. NO FURTHER TROUBLESHOOTING 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 15726495 ↗
MalfunctionJul 7, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS GETTING TOO HOT TO EVEN TOUCH. THE PATIENT UNPLUGGED THE REMOTE 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 14950376 ↗
MalfunctionJun 8, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS RUNNING TOO HOT TO THE TOUCH. HAD THE PATIENT REFRAINED FROM PLACING THE READER ON TOP OF THE MONITOR AGAIN AND UNPLUGGED THE BASE. 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 14637571 ↗
MalfunctionApr 14, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. THE CALLER WAS ADVISED TO UNPLUG THE REMOTE 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 14112899 ↗
MalfunctionNov 1, 2021Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12733566 ↗
MalfunctionOct 12, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR STARTED TO SMOKE AND WAS HOT. THE MONITOR WAS UNPLUGGED. THE REMOTE 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 12615753 ↗
MalfunctionSep 13, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH THAT THE PATIENT COULD NOT TOUCH IT. 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 12461596 ↗
MalfunctionSep 2, 2021Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12418112 ↗
MalfunctionAug 30, 2021Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12387805 ↗
MalfunctionAug 18, 2021Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12337248 ↗
MalfunctionAug 18, 2021Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT CALLED TO GET HELP WITH THE REMOTE MONITOR AND WAS GETTING SHOCKED. NO TROUBLESHOOTING WAS INDICATED FOR THE PATIENT GETTING SHOCKED. THE READER IS EXPECTED TO BE REPLACED. MONITOR REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12336278 ↗
MalfunctionAug 10, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH AND WAS SMOKING. 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 12304587 ↗
MalfunctionJul 20, 2021Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12200341 ↗
MalfunctionFeb 15, 2021Overheating of Device; Overheating of Device
THE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11328105 ↗
MalfunctionDec 30, 2020Overheating of Device; Overheating of Device
THE MONITOR WAS RETUNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11099139 ↗

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-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-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-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-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-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-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	`00763000033194`
Brand	MyCareLink™
Model	24950L
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	Oct 21, 2019

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 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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