MyCareLink™ 24950J (UDI 00643169657885)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00643169657885), received between Dec 9, 2016 and Feb 20, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (10 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.

• MalfunctionFeb 20, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR READER EXPLODED. NO TROUBLESHOOTING TAKEN. SUGGESTED REPLACEMENT BUT THE PATIENT WOULD LIKE TO WAIT AFTER SPEAKING WITH THE PHYSICIAN REGARDING SENDING IN A TRANSMISSION SOONER THAN REPLACEMENT WOULD ARRIVE. 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 18737990 ↗
• MalfunctionMar 24, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE READER OF THE REMOTE MONITOR WAS TOO HOT TO TOUCH. THE PATIENT WAS ADVISED TO LEAVE THE MONITOR DISCONNECTED. 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 16612718 ↗
• MalfunctionSep 1, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. NO TROUBLESHOOTING TAKEN. THE CALLER WAS TOLD TO LEAVE THE MONITOR UNPLUGGED. 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 15337473 ↗
• MalfunctionDec 9, 2021Overheating of Device; Overheating of Device

  THE MONITOR WAS RETURNED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12970082 ↗
• MalfunctionJun 9, 2021Overheating of Device; Overheating of Device

  THE MONITOR WAS REPLACED AND RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11970729 ↗
• MalfunctionMar 8, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR CAUGHT FIRE AND THE BASE WAS DESTROYED BUT THE READER WAS INTACT. NO TROUBLESHOOTING WAS TAKEN. PATIENT DISCARDED THE DAMAGED BASE BUT STILL HAD THE RECEIVER. 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 11440933 ↗
• MalfunctionFeb 19, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR DISPLAYED A 3230 DIAGNOSTIC CODE INDICATING THE READER IS OFF THE MONITOR BASE AND HAS POWERED DOWN, IS OFF THE BASE STATION AND HAS NO BATTERY LIFE REMAINING OR THE READER IS OUT OF RANGE OF THE MONITOR. ALSO, IT BECAME SO HOT THAT IT BURNED THE PATIENT. NO TROUBLESHOOTING TAKEN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 11347443 ↗
• MalfunctionOct 27, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS OVERHEATING. 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 Consequences Or Impact To Patient

  MAUDE report 10740929 ↗
• MalfunctionSep 19, 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 10557642 ↗
• MalfunctionOct 30, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE READER WAS OVERHEATING. THE PATIENT UNPLUGGED AND PLUGGED BACK IN THE REMOTE MONITOR. 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 9255948 ↗
• MalfunctionOct 6, 2017Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE READER PORTION OF THE REMOTE MONITOR WAS HEATING UP SO MUCH THAT THE PATIENT COULD NOT HOLD IT TO THE SKIN. 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 6919915 ↗
• MalfunctionDec 9, 2016Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WAS SHOCKED BY THE REMOTE MONITOR DURING THE INTERROGATION PHASE OF A REMOTE TRANSMISSION. THE PATIENT WAS ASSURED THAT THE MONITOR DOES NOT PERFORM THERAPY TO IMPLANTED DEVICE BUT COLLECTS AND SENDS TRANSMISSIONS. THE PATIENT WAS REFERRED TO THE CLINIC TO HAVE IMPLANTED DEVICE AND MONITOR CHECKED. A FOLLOW UP CALL WAS MADE TO THE CLINIC. THE NURSE STATED THAT THE PATIENT HAD BEEN SEEN IN CLINIC TWICE SINCE THE CALL FOR A DEVICE CHECK AND FOLLOW UP AND EVERYTHING WAS WITHIN NORMAL LIMITS. BOTH THE MONITOR AND THE IMPLANTED DEVICE REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock

  MAUDE report 6160739 ↗

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, 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-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-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-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-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