MyCareLink™ 24950J (UDI 00643169705746)Recalls & reported problems

Medtronic, Inc. · MON 24950J MYCARELINK/SVC US MS2131 · Class 3

All models of MyCareLink (33)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Medtronic MyCareLink remote monitor is used with implanted heart devices. The 39 adverse event reports are all malfunctions, mostly describing overheating, sometimes with device odor, moisture damage, or reader shock, with no deaths and no injuries. There is one closed recall that started in July 2017, about possible monitoring delays for patients with multiple implanted Medtronic heart devices due to a labeling error.

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: 39
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00643169705746), received between Dec 9, 2016 and Oct 1, 2024 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (35 reports).

1 FDA recall record name this device's identifier.

9 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 16, 2026.

Reports received per month

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

Recalls naming this device

Jul 14, 2017Terminated
Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's heart devices. Potential impacts could lead to missed CareAlert notifications or device reports.
Z-0399-2018 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Device problems

Overheating of Device35
Device Emits Odor2
Inappropriate/Inadequate Shock/Stimulation1
Mechanical Problem1
Moisture Damage1
Patient Device Interaction Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions20
No Known Impact Or Consequence To Patient15
Burn(s)2
No Consequences Or Impact To Patient2
Chest Pain1

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 1, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS OVERHEATING. THE PATIENT DECIDED TO UNPLUG THE REMOTE MONITOR. FURTHERMORE, THE PATIENT WAS INFORMED TO KEEP OFF OF IT AND NO FURTHER 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 20344494 ↗
MalfunctionNov 17, 2023Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18162614 ↗
MalfunctionApr 12, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE BASE OF THE REMOTE MONITOR WAS TOO HOT TO BE TOUCHED. THE REMOTE MONITOR WAS UNPLUGGED. NO FURTHER 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 16723573 ↗
MalfunctionMar 17, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE READER OF THE REMOTE MONITOR WAS TOO HOT A COUPLE OF TIMES. 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 16568757 ↗
MalfunctionAug 24, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. THE PATIENT WAS ADVISED TO UNPLUG THE MONITOR AND NOT TO USE IT ANYMORE. 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 15284585 ↗
MalfunctionJul 12, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS BEING TOO HOT EVEN AFTER BEING UNPLUGGED FOR SEVERAL HOURS. ADVISED TO UNPLUG THE REMOTE MONITOR IMMEDIATELY AND KEEP IT 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 14986133 ↗
MalfunctionDec 27, 2021Moisture Damage; Moisture Damage
IT WAS REPORTED THAT AN OIL-LIKE SUBSTANCE WAS LEAKING FROM THE REMOTE MONITOR AND THEN IT WAS HEATING UP. THE PATIENT 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 13086821 ↗
MalfunctionDec 6, 2021Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE THE PATIENT WAS SHOCKED BY THE READER. ADVISED NOT TO TOUCH THE REMOTE MONITOR. 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 12944162 ↗
MalfunctionOct 28, 2021Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND LOST IN SHIPPING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12713224 ↗
MalfunctionOct 27, 2021Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12702943 ↗
MalfunctionSep 27, 2021Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12533754 ↗
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 12388961 ↗
MalfunctionJul 22, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS HOT TO TOUCH THAT IT LEFT MARKS ON THE NIGHTSTAND. 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 12211867 ↗
MalfunctionJul 20, 2021Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS REPLACED AND RETURNED.
Patient problems: Burn(s)
MAUDE report 12200433 ↗
MalfunctionJul 14, 2021Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12170978 ↗
MalfunctionJun 3, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS BURNT AND NO LONGER WORKS. 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 11931055 ↗
MalfunctionMay 7, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR READER WAS TOO HOT TO BE ON PATIENT'S SKIN. 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 11789877 ↗
MalfunctionFeb 10, 2021Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11307213 ↗
MalfunctionDec 30, 2020Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11099125 ↗
MalfunctionDec 2, 2020Overheating of Device; Overheating of Device
THE PATIENT BELIEVED THAT THE MONITOR WAS TOO HOT. NO TROUBLESHOOTING INDICATED. THE MONITOR WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10934673 ↗
MalfunctionOct 14, 2020Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS REPLACED AND RETURNED.
Patient problems: Burn(s)
MAUDE report 10676500 ↗
MalfunctionSep 22, 2020Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10567401 ↗
MalfunctionAug 13, 2020Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10400299 ↗
MalfunctionSep 24, 2019Overheating of Device; Overheating of Device
IT WAS FURTHER REPORTED THAT THE MONITOR HAS BEEN REPLACED AND RETURNED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9108046 ↗
MalfunctionAug 7, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS VERY HOT TO TOUCH, ALMOST BURNING THE HAND OF THE PATIENT. NO TROUBLESHOOTING TAKEN. THE REMOTE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8871592 ↗

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-2506-2020 · Jun 4, 2020 · Open, Classified
Patient Connector, Model Number 24967
Z-2505-2020 · Jun 4, 2020 · Open, Classified
CareLink SmartSync Device Manager, Model Number 24970A
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-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	`00643169705746`
Brand	MyCareLink™
Model	24950J
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	Not in Commercial Distribution
Record updated	Jul 31, 2023

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 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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