MEDTRONIC CARELINK® MONITOR 2490C15 (UDI 00643169191815)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169191815), received between Dec 4, 2020 and Nov 30, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2021Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THE PATIENT WAS BEING FOLLOWED BY HOSPICE CARE WHILE IN NURSING HOME. IT WAS INDICATED THAT THE HAD BEEN REPEATEDLY SHOCKED. A MAGNET WAS PLACED OVER THE CRT-D HOWEVER, THE PATIENT RECEIVED AN ADDITIONAL SHOCK. NO ADDITIONAL DETAILS ABOUT THE SHOCKS WERE DISCLOSED. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shock from Patient Lead(s)

  MAUDE report 12893651 ↗
• MalfunctionDec 4, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  A CLINICIAN REPORTED THAT THE MONITOR SHOCKED THE PATIENT. NO TROUBLESHOOTING INDICATED. THE MONITOR WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10949772 ↗

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