CareLink® Monitor 2490G23Recalls & reported problems
Medtronic, Inc. · MON 2490G23 CARELINK MR5 USA · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169402904), received between Aug 9, 2017 and Aug 9, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Battery Problem” (1 report).
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
Device problems
- Battery Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 9, 2017Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERIES IN THE REMOTE MONITOR LEAKED. THE MONITOR IS EXPECTED TO BE REPLACED AND RETURNED. NO PATIENT COM PLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6781972 ↗
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, ClassifiedMedtronic 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, ClassifiedMedtronic 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, ClassifiedMedtronic 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, ClassifiedMedtronic 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, ClassifiedCareLink SmartSync Device Manager, Model Number 24970A
- Z-2506-2020 · Jun 4, 2020 · Open, ClassifiedPatient Connector, Model Number 24967
- Z-0845-2019 · Jan 17, 2019 · TerminatedMedtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
- Z-0400-2018 · Jul 14, 2017 · TerminatedMyCareLink 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 · TerminatedMyCareLink 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 · TerminatedMedtronic Carelink Monitor Model 2490C. The Medtronic CareLink Monitor Model 2490C is designed to automatically gather information from the implanted heart device. This automatic w
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- Entrant™ CDDRA300QSt. Jude Medical, Inc. · Pacemaker/icd/crt non-implanted components1 recall2 deaths158 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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