MyCareLink™ 24950KRecalls & reported problems

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

All models of MyCareLink (33)

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

Quick summary

This is a Medtronic MyCareLink 24950K remote monitor, the home unit that wirelessly checks data from implanted heart devices. The 38 reports mostly describe the monitor or its power cord getting too hot, catching fire, or giving off a burning smell; a few mention burns to the skin. There are 37 malfunctions, 1 injury, and no deaths. One recall, started in July 2017 and closed, involved labeling that could cause missed CareAlert notifications when a patient has two or more implanted Medtronic devices in the CareLink network.

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: 38
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00643169725195), received between Oct 6, 2017 and Apr 3, 2023 — classified as 1 injury, 37 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (34 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.

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 Device34
Device Emits Odor5
Inappropriate/Inadequate Shock/Stimulation1
Moisture Damage1

Patient problems

No Clinical Signs, Symptoms or Conditions17
No Known Impact Or Consequence To Patient16
No Consequences Or Impact To Patient4
Burn(s)2
Full thickness (Third Degree) Burn1
Partial thickness (Second Degree) Burn1

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 3, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR BLEW UP. THE READER WAS BOUNCING UP AND DOWN AND THE PATIENT SAW SOME SPARKS AROUND IT. THE REMOTE MONITOR WAS PROBABLY TOO HOT OR THE CORD WAS BROKEN. THE MONITOR WAS DISCONNECTED ALREADY AND THE PATIENT WAS SAFE. 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 16663470 ↗
MalfunctionMar 13, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR'S POWER CORD WAS CAUGHT IN FLAMES CAUSING IT TO BURN OUT. NO TROUBLESHOOTING TAKEN. THE POWER CORD IS EXPECTED TO BE REPLACED. THE REMOTE 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 16527995 ↗
MalfunctionOct 27, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE POWER CORD OF THE REMOTE MONITOR CAUGHT ON FIRE AND BURNED THE CURTAINS. 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 15681652 ↗
MalfunctionOct 27, 2022Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15681058 ↗
MalfunctionMay 26, 2022Device Emits Odor; Device Emits Odor
IT WAS REPORTED THAT THE REMOTE MONITOR SMELLED PLASTIC BURNING. PATIENT HAD UNPLUGGED THE MONITOR. 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 14515700 ↗
MalfunctionOct 5, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT AND THE NEW READER WAS HOT AGAINST THE PATIENT'S CHEST. NO TROUBLESHOOTING WAS 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 12577729 ↗
MalfunctionJun 9, 2021Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11970747 ↗
MalfunctionMay 25, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. 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 11876594 ↗
MalfunctionApr 30, 2021Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11753653 ↗
MalfunctionApr 16, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT WHEN THE PATIENT PLUGGED IN THE REMOTE MONITOR, IT BECAME TOO HOT TO TOUCH. NO TROUBLESHOOTING WAS PERFORMED AS PATIENT REFUSED TO PLUG IN 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 11680461 ↗
MalfunctionApr 2, 2021Device Emits Odor; Device Emits Odor
THE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11610875 ↗
MalfunctionMar 9, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR OVERHEATED AND FLASHED CONSTANTLY. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. 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 11446313 ↗
MalfunctionFeb 19, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS HOT TO TOUCH AND WAS OVERHEATING. IT WAS NOTED THAT THE MONITOR WAS ALWAYS PLUGGED IN AND THE READER WAS ALWAYS CHARGED. 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 11353626 ↗
MalfunctionJan 15, 2021Moisture Damage
THE MONITOR WAS RETUNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11176004 ↗
MalfunctionDec 8, 2020Overheating of Device; Overheating of Device
THE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10972044 ↗
MalfunctionNov 19, 2020Overheating of Device; Overheating of Device
THE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10868213 ↗
MalfunctionSep 21, 2020Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10564258 ↗
MalfunctionJul 22, 2020Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10306726 ↗
MalfunctionJul 8, 2020Overheating of Device; Overheating of Device
THE MONITOR WAS RETUNED AND REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10248527 ↗
MalfunctionJul 6, 2020Overheating of Device; Overheating of Device
THE REPORTER ADVISED THAT THE MONITOR WAS OVER HEATING. 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 Consequences Or Impact To Patient
MAUDE report 10231681 ↗
MalfunctionMay 4, 2020Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS RETURNED AND REPLACED.
Patient problems: Burn(s)
MAUDE report 10020002 ↗
MalfunctionFeb 28, 2020Overheating of Device; Overheating of Device
THE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9770574 ↗
MalfunctionDec 3, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS OVERHEATING. 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 Known Impact Or Consequence To Patient
MAUDE report 9403325 ↗
MalfunctionSep 18, 2019Device Emits Odor; Overheating of Device; Device Emits Odor; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS OVERHEATING AND HAD A BURNING SMELL. 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 Known Impact Or Consequence To Patient
MAUDE report 9083011 ↗
MalfunctionSep 17, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS SMOKING. NO TROUBLESHOOTING TAKEN. THE MONITOR REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9076178 ↗

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-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-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-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	`00643169725195`
Brand	MyCareLink™
Model	24950K
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	Mar 5, 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 · 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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