MyCareLink™ 24950KLQ (UDI 00643169725386)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169725386), received between May 16, 2018 and Aug 6, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (7 reports).

1 FDA recall record name this device's identifier.

9 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 18, 2026.

Recalls naming this device

1. Jul 14, 2017Class IITerminated

   Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's heart devices. Potential impacts could lead to missed CareAlert notifications or device reports.

   Z-0399-2018 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR POWER CORD HAD A BURNT AREA ON IT. NO TROUBLESHOOTING WAS TAKEN. THE REMOTE MONITOR POWER CORD IS EXPECTED TO BE REPLACED. THE REMOTE 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 12291759 ↗
• MalfunctionOct 13, 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 10669198 ↗
• MalfunctionJul 2, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR READER HEAD WAS TOO HOT TO TOUCH WHEN DOING A MANUAL REPORT. 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 Consequences Or Impact To Patient

  MAUDE report 10222942 ↗
• MalfunctionSep 26, 2019Overheating of Device; Overheating of Device

  THE MONITOR WAS REPLACED AND RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9124992 ↗
• MalfunctionJun 14, 2019Device Emits Odor; Overheating of Device; Device Emits Odor; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR BASE WAS WARM AND SMELLED LIKE PLASTIC BURN. THE PATIENT WAS ADVISED TO DISCONNECT THE MONITOR IMMEDIATELY. 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 8699983 ↗
• MalfunctionNov 15, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD BEEN LEAKING A GREASY FLUID FOR A WEEK. THE PATIENT WAS ADVISED ABOUT MONITOR REPLACEMENT. THE REMOTE MONITOR WAS 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 8072923 ↗
• MalfunctionOct 22, 2018Device Emits Odor; Device Emits Odor

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD A BURNING SMELL. ADVISED TO DISCONNECT THE REMOTE MONITOR .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 7990299 ↗
• MalfunctionAug 23, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE WAND PORTION OF THE REMOTE MONITOR HAD EXCESSIVE HEATING. THE DOCTOR STATED THAT THE PATIENT HAD A RED MARK ON THE SKIN FROM THE MANUAL TRANSMISSION FROM USING THE WAND. THE DOCTOR ALSO STATED, FIRST DEGREE BURN, NO BLISTERS BUT A RED MARK THAT WAS THE EXACT SIZE OF THE WAND. NO INTERVENTION WAS DONE AND PATIENT WAS NOT HOSPITALIZED. NO TROUBLESHOOTING TAKEN. 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 7809186 ↗
• MalfunctionJun 18, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS "SO HOT" THAT THE PATIENT CAN BARELY TOUCH THE MONITOR AND WAS EVEN HOT TO THE TOUCH. EXPLAINED SOME WARMTH IS NORMAL BUT IT SHOULD NOT BE SO HOT THAT THE PATIENT CANNOT TOUCH IT. THE PATIENT TRIED LEAVING THE MONITOR DISCONNECTED FOR A WHILE, IT WILL COOL DOWN BUT THEN IT WILL GET VERY HOT AGAIN. 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 7609469 ↗
• MalfunctionMay 16, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR'S READER WAS SMOKING. ADVISED TO RETURN READER AND THE REMOTE MONITOR. ASKED WHEN READER STARTED SMOKING, PATIENT STATED SIX DAYS AGO. THE PATIENT STATED THE NIGHT BEFORE THE MONITOR WAS FLASHING ON AND OFF, THE PATIENT PUT A TOWEL OVER THE SCREEN THEN READER STARTED SMOKING THE NEXT MORNING. 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 7517911 ↗

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, Classified
  Medtronic 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, Classified
  Medtronic 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, Classified
  Medtronic 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, Classified
  Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model N
• Z-2506-2020 · Jun 4, 2020 · Open, Classified
  Patient Connector, Model Number 24967
• Z-2505-2020 · Jun 4, 2020 · Open, Classified
  CareLink SmartSync Device Manager, Model Number 24970A
• Z-0845-2019 · Jan 17, 2019 · Terminated
  Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
• Z-0400-2018 · Jul 14, 2017 · Terminated
  MyCareLink 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 · Terminated
  Medtronic Carelink Monitor Model 2490C. The Medtronic CareLink Monitor Model 2490C is designed to automatically gather information from the implanted heart device. This automatic w