MyCareLink Smart™ 25000 (UDI 00643169666320)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169666320), received between Sep 11, 2018 and Feb 13, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (3 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-0400-2018 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Overheating of Device

  IT WAS REPORTED THAT THE MYCARELINK SMART READER WAS OVERHEATING AND A BURNING SENSATION ON THE CHEST WAS EXPERIENCED BY THE PATIENT WHILE USING IT. NO TROUBLESHOOTING TAKEN. THE RESOLUTION WAS TO REPLACE THE SMART READER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333630 ↗
• MalfunctionSep 12, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE READER WAS LEAKING ACID. THE PATIENT LEFT THE BATTERIES IN AND WAS ADVISED TO TAKE OUT THE BATTERIES AFTER USING THE READER, SO IT DOES NOT GET DAMAGED BY CORROSION. THE READER 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 23036695 ↗
• MalfunctionJun 23, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE SMART READER'S BATTERY WAS LEAKING. THE READER WAS CLEANED WELL BUT STILL WAS NOT WORKING. THE SMART READER 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 22306563 ↗
• MalfunctionApr 9, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE MOBILE READER WAS OVERHEATING ONCE THE BATTERIES WERE PUT IN TO HAVE THE READING DONE. A NEW READER WAS SENT TO 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 9944195 ↗
• MalfunctionSep 11, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED BY THE CALLER THAT WHEN THE PATIENT PLACED THE READER OVER THE IMPLANTED DEVICE THE PATIENT PULLED THE READER AWAY WHILE PERFORMING A TRANSMISSION BECAUSE IT FELT LIKE IT WAS BURNING THE PATIENT¿S SKIN. WHEN THE PATIENT WAS ASKED IF THE READER WAS HOT TO TOUCH, THE PATIENT SAID IT WAS LIKE A MATCH WAS LIT NEXT TO HER SKIN. THE PATIENT WAS REFERRED TO THE CLINIC AND THE READER 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 7864761 ↗

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-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-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-0399-2018 · Jul 14, 2017 · Terminated
  MyCareLink 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 · 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