MyCareLink™ 24952B (UDI 00763000113797)Recalls & reported problems
Medtronic, Inc. · MON 24952B MYCARELINK/SVC USA · Class 3
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic MyCareLink remote monitor has 167 reports, with no deaths and no injuries. Many reports describe the monitor overheating, emitting smoke or odor, or leaking acid, and some describe an electric shock. Some list burns among patient effects. No recalls name this device, and reports fell from 3 in the prior 12 months to 1 in the latest 12 months.
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
- 169
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 169 adverse event reports that list this exact device (DI 00763000113797), received between Aug 1, 2018 and Sep 11, 2026 — classified as 169 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (152 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.
Reports received per month
Most reported problems
Device problems
- Overheating of Device152
- Device Emits Odor13
- Inappropriate/Inadequate Shock/Stimulation5
- Communication or Transmission Problem2
- Moisture Damage2
- Mechanical Problem1
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions114
- No Known Impact Or Consequence To Patient34
- No Consequences Or Impact To Patient31
- Burn(s)8
Recent adverse event reports
The 25 most recent of 169 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Overheating of Device
It was reported that the remote monitor was overheating. No troubleshooting indicated. A replacement monitor was ordered. 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 50730340 ↗MalfunctionSep 11, 2026Overheating of Device
It was reported that the remote monitor had smoking smell coming from the monitor and unplugged it due to concern for a potential fire. No troubleshooting indicated. 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 50729967 ↗MalfunctionAug 28, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50493879 ↗MalfunctionOct 15, 2025Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23293899 ↗MalfunctionAug 6, 2025Moisture Damage; Moisture Damage
IT WAS REPORTED THAT THE REMOTE MONITOR WAS LEAKING ACID AND WAS CORRODED. 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 22729075 ↗MalfunctionApr 29, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT UPON PLUGGING IN THE MONITOR, SMOKE BEGAN TO EMIT FROM IT. IT WAS RECOMMENDED TO KEEP THE MONITOR UNPLUGGED. THE MONITOR WAS SUBSEQUENTLY REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21927636 ↗MalfunctionSep 26, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT FOR THE LAST TWO WEEKS, THE REMOTE MONITOR WAS OVERHEATING ON THE BASE WHEN IT WAS PLUGGED IN FOR AROUND FIVE HOURS. THE PATIENT WAS ADVISED TO UNPLUG THE REMOTE MONITOR RIGHT AWAY AND 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 20309423 ↗MalfunctionMay 20, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT REPRESENTATIVE GOT AN ELECTRICAL SHOCK BY THE REMOTE MONITOR. 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 19351658 ↗MalfunctionMay 3, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS SMOKING. THE MONITOR WAS UNPLUGGED. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT C OMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19237100 ↗MalfunctionApr 15, 2024Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19110782 ↗MalfunctionMar 29, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCK WHEN THE READER WAS PUT OVER THE DEVICE. THE PATIENT HAD ALSO BEEN GETTING LITTLE ZAPS FOR THE LAST MONTH. DISCUSSED USAGE OF THE REMOTE MONITOR. WARM TRANSFERRED THE PATIENT BACK TO THE CUSTOMER REPRESENTATIVE FOR FURTHER ADVISE WITH THE READER AND REFERRED TO THE DOCTOR REGARDING THE SYMPTOMS INCURRED. NO TROUBLESHOOTING TAKEN. 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 19005882 ↗MalfunctionOct 30, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR CAUSED FIRE IN WALL AND OUTLET. THE PATIENT STATED THAT THE WIRING HAD TO BE REPAIRED AND IT WAS ONLY THE MONITOR THAT WAS PLUGGED INTO THE OUTLET. 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 18030087 ↗MalfunctionSep 11, 2023Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17720099 ↗MalfunctionJun 8, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR KEPT OVERHEATING. NO TROUBLESHOOTING TAKEN. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIE NT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17084582 ↗MalfunctionApr 7, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR AND READER WERE TOO HOT TO TOUCH. NO TROUBLESHOOTING TAKEN. THE MONITOR IS EXPECTED TO BE RE PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16703141 ↗MalfunctionApr 3, 2023Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16663490 ↗MalfunctionMar 13, 2023Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16527991 ↗MalfunctionDec 5, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR STARTED SMOKING. NO TROUBLESHOOTING WAS TAKEN AT THE TIME OF CALL. THE MONITOR IS EXPECTED T O BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15914835 ↗MalfunctionNov 2, 2022Device Emits Odor; Device Emits Odor
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15718297 ↗MalfunctionOct 21, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR CAUGHT ON FIRE. 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 15649951 ↗MalfunctionOct 11, 2022Device Emits Odor; Device Emits Odor
IT WAS REPORTED THAT THE REMOTE MONITOR WAS GIVING OFF A WEIRD SMELL. 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 15575180 ↗MalfunctionOct 3, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS HOT TO TOUCH AND THE PATIENT WAS AFRAID IT WOULD CATCH FIRE. THE PATIENT WAS ASKED TO UNPLUG THE 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 15532129 ↗MalfunctionSep 30, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE READER WAS TOO HOT TO 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 Clinical Signs, Symptoms or Conditions
MAUDE report 15511281 ↗MalfunctionAug 25, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS HOT LIKE PUTTING A COFFEE CUP ON IT. THE PATIENT WAS EDUCATED NOT TO USE THE REMOTE MONITOR ANYMORE FOR OWN SAFETY. 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 15296144 ↗MalfunctionAug 17, 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 15240793 ↗
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-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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page