MyCareLink™ 24950ERecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00643169452060), received between Dec 7, 2017 and Nov 3, 2022 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (8 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 16, 2026.

Recalls naming this device

1. Jul 14, 2017Terminated

   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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2022Overheating of Device; Overheating of Device

  THE MONITOR WAS RETURNED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15722025 ↗
• MalfunctionOct 10, 2022Moisture Damage; Use of Device Problem; Moisture Damage; Use of Device Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR'S BASE SEEMED TO BE LIKE LEAKING SOMETHING OR LOOKED WEIRD. 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 15569736 ↗
• MalfunctionMay 20, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. NO TROUBLESHOOTING INDICATED. THE REMOTE MONITOR IS EXPECTED TO BE REP LACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14461602 ↗
• MalfunctionMar 8, 2022Moisture Damage; Device Emits Odor; Electrical Shorting; Moisture Damage; Device Emits Odor; Electrical Shorting

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD BLEW A CIRCUIT AND STARTED TO SMELL A FIRE. IT WAS ALSO REPORTED THAT THERE WAS A BROWN GEW COMING FROM INSIDE THE REMOTE 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 13685908 ↗
• MalfunctionFeb 17, 2022Device Emits Odor; Device Emits Odor

  THE PATIENT'S WIFE REPORTED THAT THE MONITOR MADE A BURNING WIRE SMELL AND THAT THE MONITOR WAS HOT. IT WAS ADVISED TO UNPLUG THE MONITOR AND TO LEAVE IT UNPLUGGED. NO FURTHER TROUBLESHOOTING STEPS WERE 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 13547187 ↗
• MalfunctionApr 23, 2021Device Emits Odor; Device Emits Odor

  THE MONITOR WAS RETURNED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11720674 ↗
• MalfunctionOct 19, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE MONITOR WAS OVERHEATING AND WAS VERY HOT. THE PATIENT UNPLUGGED THE MONITOR. NO FURTHER TROUBLESHOOTING WAS DONE. THE MONITOR WOULD BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10695507 ↗
• MalfunctionSep 28, 2020Overheating of Device; Overheating of Device

  THE MONITOR WAS RETURNED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10591693 ↗
• MalfunctionSep 22, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE MONITOR WAS EXTREMELY HOT AND THE PATIENT WAS SCARED TO KEEP THE MONITOR PLUGGED IN BECAUSE IT MIGHT START A FIRE. IT WAS ALSO STATED THAT THE PATIENT DIDN'T FEEL SAFE. NO TROUBLESHOOTING TAKEN. THE MONITOR WOULD BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10565369 ↗
• MalfunctionAug 31, 2018Overheating of Device; Power Problem; Overheating of Device; Power Problem

  IT WAS REPORTED THAT THE POWER CORD OF THE REMOTE MONITOR GOT BURNED. NO TROUBLESHOOTING TAKEN. A NEW POWER CORD WILL BE SENT OUT. THE PATIENT MAY CALL BACK IF THE REMOTE MONITOR DOES NOT POWER ON. THE MONITOR REMAINS 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 7837380 ↗
• MalfunctionApr 10, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED BY THE CLINICIAN THAT THE PATIENT SAW THE MONITOR BLINKING, HELD THE WAND OVER THE DEVICE TO DO A FULL REPORT, BUT THE DEVICE BEGAN TO FEEL HOT AND SKIN TURNED RED. THE PATIENT STOPPED PLACING THE MONITOR READER OVER THE DEVICE AND NO FURTHER REACTION. 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 7415771 ↗
• MalfunctionDec 7, 2017Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD STEAM COMING OUT OF THE BOTTOM SIDE OF THE READER. THE CALLER WAS ADVISED TO UNPLUG THE RADER FROM POWER AND LEAVE UNPLUGGED. A NEW MONITOR WAS ORDERED FOR THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7091338 ↗

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-2505-2020 · Jun 4, 2020 · Open, Classified
  CareLink SmartSync Device Manager, Model Number 24970A
• Z-2506-2020 · Jun 4, 2020 · Open, Classified
  Patient Connector, Model Number 24967
• 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