MEDTRONIC CARELINK® MONITOR 2490C15 (UDI 00643169334717)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169334717), received between Dec 6, 2017 and Jun 17, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (2 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.

• MalfunctionJun 17, 2021Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE REMOTE MONITOR MADE A POPPING NOISE. 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 12021356 ↗
• MalfunctionJun 10, 2021Device Emits Odor; Device Emits Odor

  THE MONITOR WAS RETURNED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11973054 ↗
• MalfunctionFeb 8, 2018Break; Break

  IT WAS REPORTED THAT THE REMOTE MONITOR'S POWER CORD PRONGS CAME OFF. 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 7256525 ↗
• MalfunctionDec 7, 2017Inappropriate/Inadequate Shock/Stimulation; Communication or Transmission Problem; Inappropriate/Inadequate Shock/Stimulation; Communication or Transmission Problem

  THE MONITOR WAS REPLACED AND RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7092172 ↗
• MalfunctionDec 6, 2017Overheating of Device; Communication or Transmission Problem; Overheating of Device; Communication or Transmission Problem

  IT WAS FURTHER REPORTED THAT THE MONITOR HAS BEEN REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7089979 ↗

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-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