MyCareLink™ 24950LLQ (UDI 00763000113995)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 the Medtronic MyCareLink 24950LLQ, a home monitor/reader that relays data from an implanted pacemaker, ICD or CRT device. The 32 reports mostly describe the unit getting extremely hot — sometimes too hot to touch, once hot enough to nearly burn a patient, and a few times giving off a burning smell or leaving burn marks on the metal contacts. No deaths and no injuries were reported, and there are no recalls naming 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
- 32
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00763000113995), received between Oct 18, 2018 and Mar 13, 2023 — classified as 32 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (28 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 Device28
- Device Emits Odor4
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Known Impact Or Consequence To Patient10
- No Consequences Or Impact To Patient6
- Burn(s)1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2023Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16527977 ↗MalfunctionOct 3, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. THE PATIENT HAD UNPLUGGED THE REMOTE MONITOR. NO FURTHER TROUBLESHOOTING 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 15527194 ↗MalfunctionJun 1, 2022Device Emits Odor; Device Emits Odor
IT WAS REPORTED THAT THE REMOTE MONITOR GOT REALLY HOT AND IT STARTED TO SMELL LIKE IT WAS BURNING WHERE THE POWER SUPPLY CORD WAS PLUGGED IN. 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 14569460 ↗MalfunctionApr 21, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR HAD BURNT MARKS ON THE METAL CONTACTS. NO TROUBLESHOOTING INDICATED. THE REMOTE MONITOR REMAINS IN USE. THE READER WAS 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 14168070 ↗MalfunctionFeb 1, 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 13407504 ↗MalfunctionDec 5, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE READER ALMOST BURNT THE PATIENT BECAUSE IT WAS SO HOT. 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 12931559 ↗MalfunctionAug 27, 2021Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12376183 ↗MalfunctionAug 20, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS HOT LIKE A HEATING PAD ON HIGH. 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 12347435 ↗MalfunctionJul 20, 2021Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12200325 ↗MalfunctionJun 3, 2021Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11931082 ↗MalfunctionJun 3, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR STARTED SMOKING FROM THE BASE. PATIENT HAD UNPLUGGED AND THREW THE MONITOR AWAY. NO FURTHER 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 11929936 ↗MalfunctionMay 28, 2021Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11901558 ↗MalfunctionApr 22, 2021Overheating of Device; Overheating of Device
THE MONITOR WAS RETUNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11706686 ↗MalfunctionApr 9, 2021Overheating of Device; Overheating of Device
THE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11639565 ↗MalfunctionApr 2, 2021Overheating of Device; Overheating of Device
THE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11610923 ↗MalfunctionMar 17, 2021Device Emits Odor; Device Emits Odor
THE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11500128 ↗MalfunctionFeb 1, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE MONITOR BASE WAS HOT, AND THAT IT BURNED A SPOT ON THE WOOD NIGHTSTAND. THE PATIENT FURTHER REPORTED THAT THE MONITOR WAS STILL TOO HOT TO TOUCH WHEN IT WAS BROUGHT AND PLUGGED IN TO ANOTHER LOCATION. IT WAS ADVISED TO KEEP THE MONITOR UNPLUGGED. NO FURTHER TROUBLESHOOTING STEPS WERE 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 11257107 ↗MalfunctionOct 25, 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 10731955 ↗MalfunctionSep 15, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR OVERHEATED. 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; No Consequences Or Impact To Patient
MAUDE report 10535965 ↗MalfunctionJun 18, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. NO TROUBLESHOOTING WAS TAKEN. THE REMOTE MONITOR IS EXPECTED TO BE REP LACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10166373 ↗MalfunctionJun 4, 2020Overheating of Device; Overheating of Device
THE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10121506 ↗MalfunctionApr 27, 2020Overheating of Device; Overheating of Device
THE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 10002801 ↗MalfunctionFeb 28, 2020Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9768028 ↗MalfunctionFeb 21, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE MONITOR READER WAS SO HOT THAT IT BURNED THE PATIENT'S SKIN WHEN IT WAS PLACED ON THE CHEST. THE READER LEFT A BURN MARK BUT HAS DISAPPEARED. IT WAS FURTHER REPORTED THAT THE READER WAS HOT TO THE TOUCH; IT FELT AS HOT AS A BURNER ON THE STOVE. NO TROUBLESHOOTING INDICATED. THE MONITOR WOULD BE RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Burn(s)
MAUDE report 9737052 ↗MalfunctionNov 4, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. NO TROUBLESHOOTING WAS SPECIFIED. THE REMOTE MONITOR WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9276526 ↗
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-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
Other Pacemaker/icd/crt non-implanted components devices
- Gallant™ CDDRA500QSt. Jude Medical, Inc. · Pacemaker/icd/crt non-implanted components2 recalls33 deaths3,028 reports
- NA 229047Medtronic, Inc. · Pacemaker/icd/crt non-implanted components1 recall662 reports
- Medtronic CareLink® Programmer 2090Medtronic, Inc. · Pacemaker/icd/crt non-implanted components3 recalls559 reports
- 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 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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