MyCareLink™ 24950L (UDI 00643169552043)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00643169552043), received between May 7, 2020 and Jul 17, 2024 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (18 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS OVERHEATING. AN EMAIL WAS SENT TO THE PATIENT ASKING TO DISCONNECT THE MONITOR IF STILL PLUGGED IN. 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 19761356 ↗
• MalfunctionJun 16, 2023Overheating of Device; Overheating of Device

  THE MONITOR WAS RETURNED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17145340 ↗
• MalfunctionApr 20, 2023Overheating of Device; Overheating of Device

  THE MONITOR WAS RETURNED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16774669 ↗
• MalfunctionMar 28, 2023Overheating of Device; Overheating of Device

  THE MONITOR WAS RETURNED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629975 ↗
• MalfunctionMar 6, 2023Overheating of Device; Overheating of Device

  THE MONITOR WAS RETURNED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16484705 ↗
• MalfunctionFeb 23, 2023Overheating of Device; Overheating of Device

  THE MONITOR WAS RETURNED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16428174 ↗
• MalfunctionJan 18, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD BEEN GETTING HOT TO THE POINT THAT THE PATIENT CANNOT TOUCH IT LET ALONE HOLD IT TO THE CHEST. 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 16193295 ↗
• MalfunctionOct 21, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE MONITOR SHOCKED THE PATIENT WHEN IT WAS PUT UP TO THE CHEST. NO TROUBLESHOOTING WAS TAKEN. THEY DISCUSSED ELECTROMAGNETIC INTERFERENCES AND REFERRED TO THE PHYSICIAN. 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 15655882 ↗
• MalfunctionJun 27, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. ADVISED NOT TO TOUCH 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 14825995 ↗
• MalfunctionApr 28, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS VERY HOT AND THE PATIENT WAS WORRIED. THE PATIENT WAS ASKED TO SCALE THE HOTNESS OF THE REMOTE MONITOR FROM ONE TO TEN AND THE PATIENT ANSWERED TEN. 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 14245690 ↗
• MalfunctionDec 27, 2021Overheating of Device; Overheating of Device

  THE REMOTE MONITOR WAS REPLACED AND RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087654 ↗
• MalfunctionOct 14, 2021Overheating of Device; Overheating of Device

  THE MONITOR WAS RETURNED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12633301 ↗
• MalfunctionJul 23, 2021Device Emits Odor; Device Emits Odor

  THE MONITOR WAS RETURNED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12221353 ↗
• MalfunctionJul 16, 2021Overheating of Device; Overheating of Device

  THE MONITOR WAS RETURNED AND LOST IN SHIPPING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12185738 ↗
• MalfunctionJul 7, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR'S POWER CABLE CAUGHT ON FIRE.¿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 12129296 ↗
• MalfunctionApr 7, 2021Overheating of Device; Overheating of Device

  THE REMOTE MONITOR WAS REPLACED AND RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11628148 ↗
• MalfunctionJan 14, 2021Device Emits Odor; Device Emits Odor

  THE REMOTE MONITOR WAS REPLACED AND RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11175277 ↗
• MalfunctionSep 22, 2020Overheating of Device; Overheating of Device

  THE REMOTE MONITOR WAS REPLACED AND RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10567379 ↗
• MalfunctionSep 19, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR READER BURNED THE PATIENT DURING A MANUAL TRANSMISSION. THE PATIENT WAS GUIDED THROUGH A POWER CYCLE AND A SUCCESSFUL TRANSMISSION. NO FURTHER TROUBLESHOOTING WAS DONE. THE REMOTE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Burn(s)

  MAUDE report 10557641 ↗
• MalfunctionJul 2, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS VERY HOT TO TOUCH AND HAD OVERHEATED. NO TROUBLESHOOTING WAS TAKEN. THE REMOTE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10222956 ↗
• MalfunctionMay 26, 2020Overheating of Device; Overheating of Device

  THE REMOTE MONITOR WAS RETURNED AND REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10086093 ↗
• MalfunctionMay 7, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE OLD REMOTE MONITOR USED TO SHOCK THE PATIENT WHEN TRANSMISSION WOULD BE DONE FROM HOME. THE PATIENT WAS EDUCATED THAT THE NEW REMOTE MONITORS NO LONGER NEED TO BE PLUGGED INTO TELEPHONE AND ARE SAFER AND NEWER MODEL. THE REMOTE MONITOR WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10031840 ↗

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-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-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