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MyCareLink™ 24950GLQRecalls & reported problems

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

All models of MyCareLink (33)

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

Adverse event reports
7
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169552289), received between Dec 9, 2016 and Jan 4, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (6 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

  1. 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 Device6
  • Data Problem1

Patient problems

  • No Known Impact Or Consequence To Patient6
  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 4, 2021Overheating of Device; Overheating of Device

    IT WAS REPORTED THAT THE REMOTE MONITOR WAS OVERHEATING AND TOO HOT TO TOUCH. NO TROUBLESHOOTING WAS SPECIFIED. 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 11108373 ↗
  • MalfunctionDec 7, 2018Overheating of Device; Overheating of Device

    IT WAS REPORTED THAT THE MONITOR'S READER WAS SO HOT THAT THE PATIENT COULD NOT PUT IT UP AGAINST HERSELF. 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 8140724 ↗
  • MalfunctionNov 20, 2018Overheating of Device; Overheating of Device

    IT WAS REPORTED THAT THE REMOTE MONITOR EXPLODED. NO TROUBLESHOOTING INDICATED. THE MONITOR 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 8089723 ↗
  • MalfunctionOct 16, 2018Data Problem; Data Problem

    IT WAS REPORTED THAT THE PATIENT RECEIVED A LETTER FROM THE CLINIC SAYING THAT THE CLINIC WAS NOT RECEIVING THE CORRECT INFORMATION FROM THE PATIENT. NO TROUBLESHOOTING INDICATED. THE MONITOR WAS STILL 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 7968927 ↗
  • MalfunctionJul 16, 2018Overheating of Device

    IT WAS REPORTED THAT THE REMOTE MONITOR WAS REALLY HOT AND WAS BARELY ABLE 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 7689494 ↗
  • MalfunctionAug 9, 2017Overheating of Device; Overheating of Device

    IT WAS REPORTED THAT THE REMOTE MONITOR READER WAS SO HOT, THE PATIENT COULD NOT PLACE IT AGAINST THE SKIN. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE MONITOR IS BEING RETURNED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6781725 ↗
  • MalfunctionDec 9, 2016Overheating of Device; Overheating of Device

    IT WAS REPORTED THAT THE REMOTE MONITOR DISPLAYED AN ERROR CODE INDICATING NO OR INADEQUATE CELLULAR SIGNAL. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. AN ANALOG ADAPTER WAS EXPECTED TO BE SENT. THE CALLER LATER REPORTED THAT THE MONITOR WAS STILL SEARCHING FOR A CELLULAR SIGNAL AND THAT THE MONITOR WAS HEATING UP AND WAS TOO HOT TO TOUCH. 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; No Known Impact Or Consequence To Patient

    MAUDE report 6161732 ↗

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

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Sources and updates

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