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MyCareLink™ 24950D (UDI 00643169367203)Recalls & reported problems

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

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169367203), received between Dec 9, 2016 and Dec 21, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. 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 · FDA record ↗

Most reported problems

Device problems

  • Overheating of Device2
  • Fire1

Patient problems

  • No Known Impact Or Consequence To Patient2
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 21, 2020Overheating of Device; Overheating of Device

    THE MONITOR WAS RETURNED AND REPLACED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11052825 ↗
  • MalfunctionDec 19, 2016Fire; Fire

    IT WAS REPORTED THAT THE REMOTE MONITOR CAUGHT ON FIRE AND BURNED UP AND BURNED THE PATIENT¿S BED. THE PATIENT INFORMED THE CLINIC THAT A NEW MONITOR HAS BEEN ORDERED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6186461 ↗
  • MalfunctionDec 9, 2016Overheating of Device; Overheating of Device

    IT WAS REPORTED THAT THE REMOTE MONITOR STARTED SMOKING. 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 6162366 ↗

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-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

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.