MyCareLink™ 24950M (UDI 00763000414047)Recalls & reported problems

Medtronic, Inc. · MON 24950M USA MKT M13 CORE · Class 3

All models of MyCareLink (33)

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

Adverse event reports: 12
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000414047), received between Apr 2, 2021 and Jul 10, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (11 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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Overheating of Device11
Device Emits Odor1

Patient problems

No Clinical Signs, Symptoms or Conditions11

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 10, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25775730 ↗
MalfunctionApr 20, 2026Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS OVERHEATING. NO TROUBLESHOOTING TAKEN. MONITOR HAS BEEN REPLACED. NO PATIENT COMPLICATIO NS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24925112 ↗
MalfunctionJul 22, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS OVERHEATING. PATIENT HAD UNPLUGGED THE MONITOR. 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 19792871 ↗
MalfunctionFeb 6, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS SMOKING. DISCONNECTED THE REMOTE MONITOR. 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 18649043 ↗
MalfunctionSep 21, 2023Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17789155 ↗
MalfunctionAug 24, 2023Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17611135 ↗
MalfunctionJul 5, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS OVERHEATING. ADVISED TO UNPLUG THE REMOTE MONITOR FROM THE POWER OUTLET. 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 17260697 ↗
MalfunctionJun 14, 2022Device Emits Odor; Device Emits Odor
IT WAS REPORTED THAT THE REMOTE MONITOR WAS MAKING THE PATIENT'S HOUSE SMELL LIKE BURNT PLASTIC AND WAS HOT TO TOUCH. INSTRUCTED TO LEAVE THE REMOTE MONITOR UNPLUGGED TO AVOID ANY FIRE HAZARD. 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 14683117 ↗
MalfunctionJun 1, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR READER WAS HOT TO TOUCH. THE PATIENT WAS ADVISED TO UNPLUG THE REMOTE MONITOR AND KEEP IT UNPLUGGED. THE PATIENT WAS ALSO INFORMED THAT READER BEING HOT WAS A HAZARD. 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 14566175 ↗
MalfunctionMay 8, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS OVERHEATING AND PATIENT WAS SCARED WITH THE UNIT AT HOME. PATIENT CONTACT ADVISED THE PATIENT 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 14332583 ↗
MalfunctionMar 15, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS HOT THAT IT EVEN MELTED THE POWER CORD. NO TROUBLESHOOTING INDICATED. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
MAUDE report 13768438 ↗
MalfunctionApr 2, 2021Overheating of Device; Overheating of Device
THE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11607692 ↗

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-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	`00763000414047`
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	Feb 15, 2021

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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All Pulse generator, permanent, implantable devices →

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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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