CARELINK® MONITOR 2490H10 (UDI 00643169341074)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169341074), received between May 30, 2019 and Oct 28, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (3 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 18, 2026.

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.

• MalfunctionOct 28, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE OLD BATTERIES LEAKED AND CAUSED DAMAGE TO THE COILS. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12713588 ↗
• MalfunctionDec 21, 2020Mechanical Problem; Mechanical Problem

  THE MONITOR WAS REPLACED AND RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11052702 ↗
• MalfunctionJun 4, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR SPARKED WHEN THE PATIENT TRIED TO PLUG IT IN. 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 Consequences Or Impact To Patient

  MAUDE report 10121480 ↗
• MalfunctionJan 2, 2020Overheating of Device; Overheating of Device

  THE CALLER REPORTED THAT THE PATIENT STATED THE REMOTE MONITOR WAS GETTING VERY HOT AND WAS AFRAID IT WILL START A FIRE. NO TROUBLESHOOTING TAKEN. THE REMOTE 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 9537269 ↗
• MalfunctionMay 30, 2019Overheating of Device; Overheating of Device

  THE MONITOR WAS RETURNED AND REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8652676 ↗

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-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-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