MyCareLink™ 24950M (UDI 00763000367824)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000367824), received between Jan 13, 2021 and Dec 4, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (13 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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT A REMOTE MONITOR FOR A DEFIBRILLATOR HAD BEEN OVERHEATING FOR ABOUT A MONTH. NO TROUBLESHOOTING TAKEN. THE MONITOR WILL BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715938 ↗
• MalfunctionApr 13, 2023Overheating of Device; Overheating of Device

  THE MONITOR WAS RETURNED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16730742 ↗
• MalfunctionMar 24, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. THE CALLER WAS ADVISED TO HAVE THE REMOTE MONITOR UNPLUGGED AND NOT TO USE IT ANYMORE. 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 16612619 ↗
• MalfunctionJan 17, 2023Overheating of Device; Overheating of Device

  THE MONITOR WAS RETURNED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16183241 ↗
• MalfunctionJul 12, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR AND THE READER WAS HOT TO TOUCH AND WAS INFORMED THAT IT MIGHT BE A FIRE HAZARD. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14987839 ↗
• MalfunctionJun 15, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. PATIENT UNPLUGGED THE MONITOR TO COOL DOWN THEN PLUGGED BACK IN AND THE TRANSMISSION WENT THROUGH. NO FURTHER TROUBLESHOOTING 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 14696059 ↗
• MalfunctionMar 20, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE READER WAS TOO HOT TO TOUCH. NO FURTHER TROUBLESHOOTING DONE FOR THE READER BEING 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

  MAUDE report 13830986 ↗
• MalfunctionMar 9, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS OVERHEATING. NO TROUBLESHOOTING INDICATED. THE MONITOR IS EXPECTED TO BE REPLACED. NO PA TIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13712304 ↗
• MalfunctionDec 3, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. 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 12922585 ↗
• MalfunctionNov 22, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE PATIENT DID NOT KEEP THE REMOTE MONITOR PLUGGED IN AT ALL TIMES BECAUSE THE MONITOR BASE AND READER GOT TOO HOT IF PLUGGED IN. NO TROUBLESHOOTING WAS 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 12856241 ↗
• MalfunctionSep 9, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. NO TROUBLESHOOTING WAS 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 12447241 ↗
• MalfunctionApr 27, 2021Overheating of Device; Overheating of Device

  THE MONITOR WAS REPLACED AND RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11730976 ↗
• MalfunctionJan 13, 2021Device Emits Odor; Overheating of Device; Device Emits Odor; Overheating of Device

  THE MONITOR WAS REPLACED AND RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11168445 ↗

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-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-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