MyCareLink™ 24950LLQ (UDI 00763000114015)Recalls & reported problems
Medtronic, Inc. · MON 24950LLQ MYCARELINK/SVC LINQ USA · Class 3
All models of MyCareLink (33)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a Medtronic MyCareLink home monitor, the plug-in unit that reads data from a heart device and sends it to the patient's clinic. The 34 reports mostly describe the monitor getting very hot, once hot enough that patients unplugged it, and one that was reported on fire; a few mention a burning smell. No deaths or injuries were reported, and 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
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00763000114015), received between Apr 2, 2019 and Apr 7, 2023 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (30 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
Device problems
- Overheating of Device30
- Device Emits Odor3
- Break1
- Inappropriate/Inadequate Shock/Stimulation1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Known Impact Or Consequence To Patient15
- No Consequences Or Impact To Patient6
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS CAUGHT ON FIRE. NO TROUBLESHOOTING TAKEN. THE MONITOR IS EXPECTED TO BE REPLACED. NO PAT IENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16703175 ↗MalfunctionJul 1, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. ADVISED THE PATIENT NOT TO TOUCH THE MONITOR AND DISCONNECTED. 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 14892296 ↗MalfunctionFeb 9, 2022Overheating 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 13498584 ↗MalfunctionOct 28, 2021Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12715699 ↗MalfunctionAug 17, 2021Device Emits Odor; Device Emits Odor
IT WAS REPORTED THAT THE PATIENT SMELLED SMOKE. PATIENT HAD UNPLUGGED POWER TO MONITOR AND WAS NOT COMFORTABLE WITH TROUBLESHOOTING THE MONITOR. 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 12334795 ↗MalfunctionAug 5, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS HOT TO TOUCH ON THE BASE OVER THE WEEKEND AND THOUGHT THAT IT WOULD BURN THE NIGHTSTAND. THE PATIENT UNPLUGGED THE REMOTE MONITOR. NO FURTHER TROUBLESHOOTING WAS PERFORMED 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 12278955 ↗MalfunctionJul 7, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR 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 12129217 ↗MalfunctionJun 25, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS VERY HOT. HAD THE PATIENT UNPLUG THE MONITOR DUE TO IT BEING A FIRE HAZARD. 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 12072015 ↗MalfunctionJun 24, 2021Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12059861 ↗MalfunctionJun 10, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS HOT TO THE TOUCH AND BURNING WHEN PATIENT PLACED IT ON 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 11975715 ↗MalfunctionFeb 1, 2021Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE READER SHOCKED THE PATIENT DURING AN ATTEMPT TO SEND A TRANSMISSION. THE PATIENT WAS ADVISED TO UNPLUG THE MONITOR. NO FURTHER TROUBLESHOOTING STEPS WERE 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 11257357 ↗MalfunctionJan 21, 2021Overheating of Device; Overheating of Device
THE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11207634 ↗MalfunctionDec 23, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE MONITOR WAS HOT TO THE TOUCH. IT WAS GETTING EXTREMELY HOT; ALMOST BURNING. THE PATIENT WAS ADVISED TO UNPLUG THE MONITOR. 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 11062951 ↗MalfunctionOct 2, 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 10618470 ↗MalfunctionSep 14, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE PATIENT HAD A PROBLEM WITH THE MONITOR; IT MADE A LOUD NOISE AND BLEW THE ELECTRICAL CIRCUIT TWICE. THE PATIENT FURTHER DESCRIBED THAT THE MONITOR WAS A SAFETY HAZARD. NO TROUBLESHOOTING WAS INDICATED. THE MONITOR WOULD BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10528299 ↗MalfunctionAug 25, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS 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; No Consequences Or Impact To Patient
MAUDE report 10447543 ↗MalfunctionJul 15, 2020Overheating of Device; Overheating of Device
THE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10274802 ↗MalfunctionJul 9, 2020Overheating of Device; Overheating of Device
THE PATIENT REPORTED THAT THE MONITOR WAS HOT AND COULD NOT PICK IT UP. 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 Consequences Or Impact To Patient
MAUDE report 10249531 ↗MalfunctionJun 19, 2020Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10173533 ↗MalfunctionMar 30, 2020Overheating of Device; Overheating of Device
THE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9898049 ↗MalfunctionMar 24, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE MONITOR WAS TOO HOT TO TOUCH. NO TROUBLESHOOTING INDICATED. THE MONITOR WOULD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9873395 ↗MalfunctionDec 20, 2019Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9501544 ↗MalfunctionDec 3, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR BURST INTO FLAMES OR WAS CAUGHT ON FIRE. NO TROUBLESHOOTING TAKEN; THE MONITOR WAS THROWN IN THE TRASH WHEN THE FIRE DEPARTMENT WAS CALLED TO HOME. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9407568 ↗MalfunctionOct 11, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE MONITOR WAS HOT OR BOILING HOT TO THE 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 Known Impact Or Consequence To Patient
MAUDE report 9177958 ↗MalfunctionAug 30, 2019Overheating of Device; Overheating of Device
THE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8951295 ↗
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-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-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-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-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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