MyCareLink™ 24952ARecalls & reported problems
Medtronic, Inc. · MON 24952A MYCARELINK/SVC USA · Class 3
All models of MyCareLink (33)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This MyCareLink 24952A monitor is a Medtronic remote monitor used to relay data from an implanted pacemaker, ICD, or CRT device to the patient's care team. The 51 adverse event reports mostly describe the monitor or its power cord getting too hot, sometimes smoking or triggering smoke alarms; a few mention odor, moisture, or a reading problem. There are no deaths and no injuries, though two reports mention burns. 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
- 51
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00763000014384), received between Apr 10, 2018 and Jan 22, 2026 — classified as 51 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (46 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 Device46
- Device Emits Odor6
- Fire1
- Moisture Damage1
- Output Problem1
- Temperature Problem1
Patient problems
- No Known Impact Or Consequence To Patient23
- No Clinical Signs, Symptoms or Conditions19
- No Consequences Or Impact To Patient9
- Burn(s)2
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2026Overheating of Device
IT WAS REPORTED THAT A REMOTE MONITOR STARTED SMOKING. THE PATIENT UNPLUGGED THE MONITOR, AND NO FURTHER TROUBLESHOOTING WAS TAKEN. A NEW 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 24144134 ↗MalfunctionJun 30, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT SMOKE WAS COMING OUT FROM THE REMOTE MONITOR. NO TROUBLESHOOTING TAKEN. THE MONITOR IS EXPECTED TO BE REPLACED IMMEDIATELY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22359579 ↗MalfunctionOct 16, 2024Overheating 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 20460929 ↗MalfunctionApr 10, 2023Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16706826 ↗MalfunctionMar 31, 2023Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16654623 ↗MalfunctionMay 27, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE POWER CORD GOT TOO HOT TO TOUCH. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. 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 14526730 ↗MalfunctionApr 27, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR READER SET OFF THE SMOKE DETECTOR. IT WAS STATED THAT THE MONITOR HAD BEEN UNPLUGGED. 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 14221006 ↗MalfunctionMar 9, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT 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 Clinical Signs, Symptoms or Conditions
MAUDE report 13712299 ↗MalfunctionDec 16, 2021Moisture Damage; Moisture Damage
IT WAS REPORTED THAT THE REMOTE MONITOR WAS HOT TO THE TOUCH AND WAS STICKY UNDER THE BASE. IT WAS STATED THAT ITS EITHER A MELTING PAINT OR THE PLASTIC STARTED TO MELT. NO TROUBLESHOOTING INDICATED. 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 13018835 ↗MalfunctionOct 21, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS HOT ENOUGH FOR THE PATIENT NOT TO HOLD IT. 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 12675095 ↗MalfunctionAug 11, 2021Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12306633 ↗MalfunctionJun 13, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR HAD OVERHEATED. THE PATIENT HAD TO KEEP THE REMOTE MONITOR UNPLUGGED FOR IT TO COOL DOWN. NO FURTHER 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 11989238 ↗MalfunctionMay 25, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO THE TOUCH. NO TROUBLESHOOTING WAS INDICATED. 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 11876601 ↗MalfunctionApr 21, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR READER HAD BEEN OVERHEATING FOR A FEW MONTHS NOW. 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 11700489 ↗MalfunctionMar 17, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR'S READER WAS TOO HOT 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 Clinical Signs, Symptoms or Conditions
MAUDE report 11500131 ↗MalfunctionFeb 26, 2021Overheating of Device; Overheating of Device
MalfunctionFeb 19, 2021Device Emits Odor; Device Emits Odor
IT WAS REPORTED THAT THE REMOTE MONITOR SMELLED LIKE A WIRE BURNT ODOR WHEN THE MONITOR WAS 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 11352669 ↗MalfunctionDec 3, 2020Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10939011 ↗MalfunctionSep 22, 2020Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10565362 ↗MalfunctionSep 16, 2020Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10541403 ↗MalfunctionSep 16, 2020Overheating of Device; Output Problem; Overheating of Device; Output Problem
IT WAS REPORTED THAT THE REMOTE MONITOR WAS HOT AND BURNED THE PATIENT'S SKIN WHEN THE READER WAS PICKED UP OFF THE REMOTE MONITOR. 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: Burn(s)
MAUDE report 10541357 ↗MalfunctionSep 14, 2020Overheating of Device; Overheating of Device
A CLINICIAN REPORTED THAT THE PATIENT'S REMOTE MONITOR WAS OVERHEATING. NO TROUBLESHOOTING INDICATED. THE MONITOR WOULD BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10528261 ↗MalfunctionAug 17, 2020Device Emits Odor; Device Emits Odor
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10413881 ↗MalfunctionAug 6, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT AND THE PATIENT WAS AFRAID THAT IT WOULD BURN THE SKIN. 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 10372069 ↗MalfunctionJul 3, 2020Overheating of Device; Overheating of Device
THE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Patient Involvement
MAUDE report 10228432 ↗
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, 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-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-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-2505-2020 · Jun 4, 2020 · Open, ClassifiedCareLink SmartSync Device Manager, Model Number 24970A
- Z-2506-2020 · Jun 4, 2020 · Open, ClassifiedPatient Connector, Model Number 24967
- Z-0845-2019 · Jan 17, 2019 · TerminatedMedtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
- 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-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-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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