MyCareLink™ 24950M (UDI 00763000414023)Recalls & reported problems
Medtronic, Inc. · MON 24950M USA MKT M13 CORE · Class 3
All models of MyCareLink (33)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic MyCareLink device is a remote monitor for an implantable cardiac device. Reports mostly describe the monitor overheating, sometimes with odors or burnt power cords and parts, leading to replacement. There are 41 reports, with no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00763000414023), received between Apr 13, 2021 and May 11, 2026 — classified as 41 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (35 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.
Reports received per month
Most reported problems
Device problems
- Overheating of Device35
- Device Emits Odor3
- Inappropriate/Inadequate Shock/Stimulation3
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- Burning Sensation1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Overheating of Device
IT WAS REPORTED THAT A REMOTE MONITOR FOR AN IMPLANTABLE CARDIAC MONITOR (ICM) WAS OVERHEATING. 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 25144780 ↗MalfunctionMar 6, 2026Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24532654 ↗MalfunctionAug 6, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR POWER CORD WAS FOUND BURNT ALONG WITH THE POWER PLUG CONNECTED TO IT, AFTER THE PATIENT RETURNED FROM BEING OUT OF TOWN. THE PATIENT EXPRESSED FEAR OF TOUCHING THE MONITOR. NO TROUBLESHOOTING TAKEN. A REPLACEMENT 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 22728579 ↗MalfunctionMay 19, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS BECOMING SO HOT THAT SOME PARTS TURNED BLACK. THE MONITOR WAS REPLACED AS A TROUBLESHOOTING STEP. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22043503 ↗MalfunctionFeb 12, 2025Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21363978 ↗MalfunctionNov 11, 2024Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20650347 ↗MalfunctionMay 10, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE READER AND REMOTE MONITOR WERE OVERHEATING. 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 19285930 ↗MalfunctionMay 9, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS OVERHEATING. THE PATIENT WAS ADVISED NOT TO USE IT. 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 19276851 ↗MalfunctionDec 22, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18382568 ↗MalfunctionDec 5, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS OVERHEATING. THE PATIENT HAD UNPLUGGED THE MONITOR TO COOL IT DOWN. 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 18268351 ↗MalfunctionAug 4, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR OVERHEATED. 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 17460559 ↗MalfunctionMay 11, 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 PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16910952 ↗MalfunctionMay 9, 2023Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16894484 ↗MalfunctionApr 28, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT FELT A SHOCK WHEN THE READER OF THE REMOTE MONITOR WAS PLACED OVER THE PATIENT¿S CHEST. THE PATIENT WAS INFORMED THAT THE REMOTE MONITOR WOULD READ THE DEVICE INFORMATION. NO FURTHER TROUBLESHOOTING WAS INDICATED. THE PATIENT WAS REFERRED TO THE CLINIC. 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 16831302 ↗MalfunctionApr 21, 2023Device Emits Odor; Device Emits Odor
IT WAS REPORTED THAT THE REMOTE MONITOR SMELLED LIKE BURNING. THE PATIENT WAS INSTRUCTED TO UNPLUG THE REMOTE MONITOR. 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 16790922 ↗MalfunctionApr 13, 2023Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16730711 ↗MalfunctionMar 6, 2023Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16485212 ↗MalfunctionJan 19, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. THE PATIENT WAS ADVISED NOT TO USE THE MONITOR ANYMORE AND UNPLUG IT. NO FURTHER TROUBLESHOOTING 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 16209116 ↗MalfunctionDec 22, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO BE TOUCHED. IT WAS CONFIRMED THAT THE MONITOR WAS NEVER EXPOSED TO HEAT SOURCES NOR THE SUNLIGHT. 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 16038663 ↗MalfunctionDec 21, 2022Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS HOT TO TOUCH AND THE PATIENT WAS AFRAID TO PLUG IT IN BECAUSE IT CAN GENERATE FIRE. 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 16026077 ↗MalfunctionOct 26, 2022Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15673926 ↗MalfunctionOct 10, 2022Overheating 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 P ATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15571043 ↗MalfunctionOct 3, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS SMOKING. THE PATIENT WAS ADVISED TO UNPLUG THE REMOTE MONITOR AND MOVE TO AN OPEN AREA. 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 15527186 ↗MalfunctionAug 24, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH THAT THE PATIENT HAD TO UNPLUG IT. THE PATIENT WAS ADVISED TO KEEP THE MONITOR UNPLUGGED. 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 15283921 ↗MalfunctionJul 21, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR OVERHEATED AND WAS CONSIDERED HAZARDOUS. 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 15079675 ↗
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, ClassifiedMedtronic 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, ClassifiedMedtronic 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, ClassifiedMedtronic 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, ClassifiedMedtronic 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, ClassifiedPatient Connector, Model Number 24967
- Z-2505-2020 · Jun 4, 2020 · Open, ClassifiedCareLink SmartSync Device Manager, Model Number 24970A
- Z-0845-2019 · Jan 17, 2019 · TerminatedMedtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
- Z-0400-2018 · Jul 14, 2017 · TerminatedMyCareLink 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 · TerminatedMyCareLink 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 · TerminatedMedtronic 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
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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