MyCareLink™ 24950JLQ (UDI 00643169658127)Recalls & reported problems

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

All models of MyCareLink (33)

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

Adverse event reports: 10
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169658127), received between Jun 8, 2017 and May 29, 2019 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (9 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 18, 2026.

Recalls naming this device

Jul 14, 2017Class IITerminated
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 Device9
Device Emits Odor4
Smoking1

Patient problems

No Known Impact Or Consequence To Patient10

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 29, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR STARTED SMOKING. THE PATIENT SAW SMOKE COMING FROM THE SIDES OF THE REMOTE MONITOR AND THEN FROM THE SCREEN. THE PATIENT UNPLUGGED THE MONITOR AND STATED THAT THE POWER CORD HAD BURN MARKS ON AREA CONNECTING TO THE MONITOR. 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 8649942 ↗
MalfunctionMar 5, 2019Overheating of Device; Overheating of Device
THE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8392287 ↗
MalfunctionJan 17, 2019Overheating of Device; Overheating of Device
THE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8258610 ↗
MalfunctionAug 23, 2018Overheating of Device; Overheating of Device
IT WAS ALSO 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 Known Impact Or Consequence To Patient
MAUDE report 7808018 ↗
MalfunctionJul 24, 2018Device Emits Odor; Overheating of Device; Smoking; Device Emits Odor
IT WAS REPORTED THAT THE REMOTE MONITOR SMELLED LIKE IT WAS SMOKING AND READER HEAD WAS HOT TO THE TOUCH, NO CHAR OR DISCOLORATION. 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 Known Impact Or Consequence To Patient
MAUDE report 7713568 ↗
MalfunctionApr 20, 2018Device Emits Odor; Overheating of Device; Device Emits Odor; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR PLUG CAUGHT ON FIRE WHILE PLUGGED INTO A RECEPTACLE AT THE PATIENT'S HOME. 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 7446626 ↗
MalfunctionApr 16, 2018Device Emits Odor; Overheating of Device; Device Emits Odor; Overheating of Device
IT WAS REPORTED THAT THE PATIENT CLAIMED THERE HAD BEEN A HOUSE FIRE IN (B)(6) AND WAS TOLD BY THE FIRE MARSHAL THAT THE FIRE WAS INITIATED BY THE REMOTE MONITOR. THE STATEMENT WAS MADE BY THE PATIENT AND NOT BY THE STATE FIRE MARSHAL. THE PATIENT ALREADY DISCARDED THE MONITOR. THE MONITOR REPLACEMENT STATUS WAS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7432868 ↗
MalfunctionNov 16, 2017Device Emits Odor; Device Emits Odor
IT WAS REPORTED THAT THE "HOME MONITOR BURNED ON A FIRE". THE MONITOR STATUS IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7039134 ↗
MalfunctionOct 6, 2017Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE PATIENT LEFT THE MONITOR UNPLUGGED FOR A MONTH AND IT IS TOO HOT TO TOUCH. THE MONITOR IS BEING RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6924659 ↗
MalfunctionJun 8, 2017Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE READER ON THE REMOTE MONITOR WAS OVERHEATING TO ONE HUNDRED AND THRITY FOUR DEGREES. IT WAS NOTED THAT THE TEMPERATURE WAS MEASURED BY THE PATIENT USING A HEAT GUN. THE PATIENT WAS ADVISED TO UNPLUG THE MONITOR AND NOT USE IT. A NEW MONITOR WAS ORDERED FOR THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6624967 ↗

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-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	`00643169658127`
Brand	MyCareLink™
Model	24950JLQ
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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