MyCareLink™ 24950L (UDI 00643169552272)Recalls & reported problems
Medtronic, Inc. · MON 24950L USA MKT M10.2 USA MKT · Class 3
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This MyCareLink 24950L remote monitor is a bedside component used with Medtronic pacemakers and ICDs. Most of the 56 reports describe the monitor or its reader getting too hot, smoking, or throwing sparks; a few describe a burning smell or shocks patients felt were delivered. No deaths and no injuries were reported. There are no recalls for 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
- 56
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00643169552272), received between Aug 28, 2019 and Jun 19, 2026 — classified as 56 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (49 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 Device49
- Device Emits Odor4
- Inappropriate/Inadequate Shock/Stimulation3
Patient problems
- No Clinical Signs, Symptoms or Conditions44
- No Consequences Or Impact To Patient9
- No Known Impact Or Consequence To Patient4
- Burn(s)1
- Burning Sensation1
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2026Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT WAS BEING SHOCKED AND ALLEGED THE MONITOR CAUSED IT. NO TROUBLESHOOTING TAKEN. THE PATIENT WAS ADVISED THAT THE BEDSIDE MONITOR DOES NOT INDUCE ANY THERAPIES BUT RECOMMENDED GETTING THE DEVICE CHECKED AT 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 25560133 ↗MalfunctionMar 29, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR STARTED TO SMOKE AFTER THE PATIENT PLUGGED IT BACK IN. 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 19006917 ↗MalfunctionAug 29, 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 17644426 ↗MalfunctionMar 24, 2023Overheating 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 PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16612495 ↗MalfunctionFeb 24, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR EXPLODED OR THE PATIENT SAW SOME SPARKS FROM IT. THE REMOTE MONITOR WAS DISCONNECTED AND CALLED THE CLINIC. 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 16438746 ↗MalfunctionFeb 10, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR OVERHEATED. 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 16352893 ↗MalfunctionJan 3, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS HOT THAT IT ALMOST DAMAGED THE WOOD TABLE. 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 16086461 ↗MalfunctionDec 1, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE READER OF THE REMOTE MONITOR 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 15894983 ↗MalfunctionOct 11, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. THE PATIENT UNPLUGGED THE REMOTE MONITOR AND NO FURTHER TROUBLESHOOTING WAS MADE DURING THE 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 15579538 ↗MalfunctionAug 16, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR FELT WARM THAT THE PATIENT THOUGHT IT WAS A FIRE HAZARD. NO TROUBLESHOOTING WAS TAKEN. THE PATIENT WANTED TO SEE IF THE MONITOR BEHAVIOR WOULD CHANGE OVER THE NEXT FEW DAYS. 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 15237143 ↗MalfunctionJul 27, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE POWER CORD OF THE REMOTE MONITOR WAS VERY HOT AND THE CALLER THOUGHT IT WAS GOING TO START A FIRE. IT WAS NOTED THAT THE MONITOR WAS UNPLUGGED. NO FURTHER TROUBLESHOOTING WAS PERFORMED. THE POWER CORD WILL BE REPLACED. 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 15114700 ↗MalfunctionJul 22, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS OVERHEATING AND THE PATIENT UNPLUGGED IT. 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 15088229 ↗MalfunctionJun 1, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS HOT . THE PATIENT ALSO EXPERIENCED SPARKING FROM THE REMOTE MONITOR THAT MAY HAVE BEEN COMING FROM ITS POWER CORD. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE REMOTE MONITOR IS EXPECTED TO BE RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14569426 ↗MalfunctionJun 1, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE READER OF THE REMOTE MONITOR WAS BURNING THE PATIENT'S SKIN. THE CALLER 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: Burning Sensation
MAUDE report 14569134 ↗MalfunctionMay 11, 2022Device Emits Odor; Device Emits Odor
IT WAS REPORTED THAT THE REMOTE MONITOR SMELLED BURNT. NO TROUBLESHOOTING WAS 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 14364320 ↗MalfunctionApr 15, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS ASSOCIATED IN A HOUSE FIRE. NO TROUBLESHOOTING TAKEN. THE MONITOR WAS REPLACED AND THE REMOTE MONITOR RETURN STATUS WAS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14118181 ↗MalfunctionMar 8, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THERE WERE SPARKS THAT CAME OUT OF THE REMOTE MONITOR WHICH LANDED ON THE BED AND BURNED THE HOUSE DOWN. NO TROUBLESHOOTING WAS PERFORMED. THE MONITOR WILL NOT BE RETURNED THIS TIME. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13694328 ↗MalfunctionFeb 14, 2022Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13524907 ↗MalfunctionFeb 9, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE POWER CORD OF THE REMOTE MONITOR GOT A CUT OR NICK IN IT AND THE CALLER STATED THAT THERE WERE SPARKS WHEN IT WAS PLUGGED IN. THERE WAS NO KNOWN CAUSE FOR THE CUT OR NICK. EXPLAINED TO THE CALLER TO LEAVE THE REMOTE MONITOR UNPLUGGED. A POWER CORD WILL BE SENT. 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 13502832 ↗MalfunctionJan 13, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS GETTING WARM OR OVERHEATING. PATIENT HAD UNPLUGGED THE REMOTE MONITOR. 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 13250165 ↗MalfunctionNov 19, 2021Device Emits Odor; Device Emits Odor
THE MONITOR WAS RETURNED AND LOST IN SHIPPING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12849130 ↗MalfunctionOct 26, 2021Overheating of Device; Overheating of Device
THE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12701908 ↗MalfunctionSep 30, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. THE MONITOR WAS 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 12555514 ↗MalfunctionSep 22, 2021Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12511927 ↗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 12387822 ↗
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-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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- CareLink Encore™ 29901AMedtronic, Inc. · Pacemaker/icd/crt non-implanted components2 recalls474 reports
- Medtronic CareLink® Programmer 2090Medtronic, Inc. · Pacemaker/icd/crt non-implanted components3 recalls422 reports
- Medtronic CareLink® Programmer 2090Medtronic, Inc. · Pacemaker/icd/crt non-implanted components3 recalls151 reports
- Medtronic CareLink® Programmer 2090AA4Medtronic, Inc. · Pacemaker/icd/crt non-implanted components3 recalls82 reports
- Entrant™ CDDRA300QSt. Jude Medical, Inc. · Pacemaker/icd/crt non-implanted components1 recall2 deaths158 reports
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