MyCareLink™ 24950M (UDI 00763000414030)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00763000414030), received between Mar 19, 2021 and Sep 17, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Overheating of Device

  It was reported that MycareLink remote monitor was overheated. No troubleshooting indicated. A replacement remote monitor was ordered. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50800492 ↗
• MalfunctionSep 2, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50566320 ↗
• MalfunctionMay 22, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT LIFTED THE READER TO PROCESS A TRANSMISSION AND FELT A STRONG SHOCK SENSATION UNTIL THE READER WAS PUT DOWN. A NEW MONITOR WAS REQUESTED FOR THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069668 ↗
• MalfunctionDec 5, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR OVERHEATED. NO TROUBLESHOOTING TAKEN. THE MONITOR WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854057 ↗
• MalfunctionDec 5, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR OVERHEATED. INSTRUCTED TO UNPLUG THE REMOTE MONITOR, NO FURTHER TROUBLESHOOTING TAKEN. THE MONITOR WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854043 ↗
• MalfunctionDec 5, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE MONITOR WAS OVERHEATING. THE REMOTE MONITOR WAS MOVED FROM A WOODEN NIGHTSTAND TO ANOTHER LOCATION AND ELEVATED ON A WICKER BASKET SO THAT THE BOTTOM HAD ACCESS TO THE AIR. THE ISSUE WAS NOTED TO HAVE BEEN RESOLVED. THE MONITOR REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20853730 ↗
• MalfunctionAug 15, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT A SMOKE CAME OUT FROM THE REMOTE MONITOR AND THE MONITOR WAS BURNED OUT. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. 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 19992103 ↗
• MalfunctionMay 16, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS OVERHEATING AND NOT COOLING DOWN. THE PATIENT WAS INSTRUCTED TO DISCONNECT MONITOR FROM 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 19329818 ↗
• MalfunctionSep 15, 2023Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17756617 ↗
• MalfunctionApr 3, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. NO TROUBLESHOOTING TAKEN AT THE TIME OF CALL. 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 16663512 ↗
• MalfunctionMar 6, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR READER WAS TOO HOT TO TOUCH. THE MONITOR WAS DISCONNECTED AND THE PATIENT WAS INSTRUCTED TO NOT TOUCH THE MONITOR. NO FURTHER TROUBLESHOOTING TAKEN AT THE TIME OF CALL. 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 16485218 ↗
• MalfunctionFeb 9, 2023Overheating of Device; Overheating of Device

  THE MONITOR WAS RETURNED AND REPLACED.

  Patient problems: Burn(s)

  MAUDE report 16336483 ↗
• MalfunctionJan 30, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE READER OF THE REMOTE MONITOR WAS HOT AND THE PATIENT COULD NO LONGER TOUCH IT. NO TROUBLESHOOTING WAS TAKEN AT THE TIME OF CALL. 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 16264571 ↗
• MalfunctionJan 4, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD SMOKE COMING OUT OF IT. THE CALLER TRIED TO CONNECT IT AND STARTED TO SMOKE AGAIN. NO FURTHER TROUBLESHOOTING WAS MADE AT THE TIME OF THE CALL. 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 16094244 ↗
• MalfunctionNov 18, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS OVERHEATING; TOO HOT TO TOUCH WITH SMOKE COMING OUT OF IT. NO TROUBLESHOOTING WAS TAKEN AT THE TIME OF CALL. 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 15824284 ↗
• MalfunctionSep 19, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO HANDLE. THE PATIENT WAS INFORMED TO DISCONNECT THE MONITOR FROM POWER. NO FURTHER TROUBLESHOOTING WAS PERFORMED. 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 15450967 ↗
• MalfunctionSep 2, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. INSTRUCTED PATIENT TO DISCONNECT THE REMOTE 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 15348629 ↗
• MalfunctionJun 30, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS OVERHEATING AND WAS TOO HOT AFTER IT WAS CONNECTED TO THE POWER. THE REMOTE MONITOR WAS UNPLUGGED, AND THE CALLER WAS ASKED NOT TO CONNECT THE MONITOR TO THE POWER AGAIN. THE MONITOR WILL BE RETURNED. NO REPLACEMENT MONITOR COULD BE ORDERED DUE TO THE PATIENT NOT ENROLLED ON THE NETWORK. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14877690 ↗
• MalfunctionJan 13, 2022Device Emits Odor; Device Emits Odor

  IT WAS REPORTED THAT THE REMOTE MONITOR SMELLED ELECTRICAL. PATIENT HAD UNPLUGGED THE MONITOR. NO FURTHER 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 13249977 ↗
• MalfunctionMay 20, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR OVERHEATED. THE PATIENT WAS ADVISED TO REMOVE THE MONITOR FROM THE OUTLET. 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 11859888 ↗
• MalfunctionMar 19, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS SO HOT THAT IT MELTED THE WOOD OFF THE TABLE. IT WAS STATED THAT THE MONITOR WAS PLUGGED INTO AN EXTENSION CORD. THE PATIENT WAS ENCOURAGED TO USE THE WALL OUTLET BUT UNABLE TO DO BECAUSE OF LIMITED SPACE. THE PATIENT WAS ADVISED TO TRY UNPLUGGING THE MONITOR WHEN NOT IN USE AND THEN PLUGGING IT BACK IN WHEN NEEDED. IN THE MEANTIME, THE PATIENT WOULD CONSULT WITH THE CLINIC FOR OTHER OPTIONS. THE MONITOR REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11529021 ↗

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-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-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-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-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