MyCareLink™ 24950L (UDI 00763000033217)Recalls & reported problems
Medtronic, Inc. · MON 24950L USA MKT M10.2 · Class 3
All models of MyCareLink (33)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00763000033217), received between Mar 17, 2020 and Sep 19, 2022 — classified as 22 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (20 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 Device20
- Electrical Shorting1
- Inappropriate/Inadequate Shock/Stimulation1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 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 15445144 ↗MalfunctionSep 1, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE READER OF REMOTE MONITOR WAS TOO HOT. IT WAS NOTED THAT THE PATIENT UNPLUGGED THE MONITOR TO AVOID POSSIBLE INJURIES. 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 15337320 ↗MalfunctionAug 10, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS VERY HOT. THE MONITOR WAS UNPLUGGED BECAUSE OF CONCERN THAT THE PATIENT WILL GET BURNED. 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 15201905 ↗MalfunctionJun 24, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR GOT TOO HOT TO TOUCH. THE PATIENT WAS INSTRUCTED TO UNPLUG THE REMOTE MONITOR AND NOT TO TOUCH. 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 14806499 ↗MalfunctionMay 8, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS SPARKING. 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 14332579 ↗MalfunctionApr 27, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR MIGHT HAVE SPARKED. 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 14221064 ↗MalfunctionOct 6, 2021Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12584480 ↗MalfunctionSep 9, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR READER WAS HOT TO THE TOUCH AND THE PATIENT WOULD NOT WANT TO PUT IT ON THE SKIN. THE PATIENT WAS ADVISED 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 12447309 ↗MalfunctionSep 1, 2021Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12411059 ↗MalfunctionAug 30, 2021Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12387703 ↗MalfunctionAug 13, 2021Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12321219 ↗MalfunctionAug 5, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR READER WAS HOT WHEN IT WAS PLACED ON THE CHEST THAT IT HURT THE PATIENT. 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 12284400 ↗MalfunctionAug 4, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS HOT TO TOUCH LIKE A HOT STOVE. 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 12277972 ↗MalfunctionJul 23, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR GOT REALLY HOT THAT IT ALMOST CAUGHT ON FIRE. THERE WERE SCORCH MARKS WHERE THE POWER CORD MEETS THE OUTLET AND AT THE BASE OF THE MONITOR. 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 12219470 ↗MalfunctionJun 10, 2021Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11975307 ↗MalfunctionMar 22, 2021Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11542017 ↗MalfunctionJan 15, 2021Electrical Shorting
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11176212 ↗MalfunctionAug 7, 2020Overheating of Device; Overheating of Device
THE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10382926 ↗MalfunctionJun 5, 2020Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10122242 ↗MalfunctionMay 8, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT WITHIN 30 SECONDS OF HAVING THE MONITOR READER OVER THE PACEMAKER, THE PATIENT FELT REALLY STRONG "ELECTRIC JOLT." THE PATIENT'S HEART CONTRACTED SOMETHING AWFUL. THE PATIENT FELT IT IN THE THROAT AND FELT THAT IT WAS GIVING THE PATIENT A HEART ATTACK. THE USE OF THE MONITOR WAS EXPLAINED TO THE PATIENT AND WAS ENCOURAGED TO CALL THE DOCTOR FOR THE SYMPTOMS. NO FURTHER TROUBLESHOOTING STEPS WERE PERFORMED. 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 10037421 ↗MalfunctionMar 24, 2020Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9870805 ↗MalfunctionMar 17, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS DAMAGED WHEN THE BATTERIES BLEW UP IN THE HAND READER. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. 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 9842736 ↗
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-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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