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HeartMate 3 LVAD

With Full Maglev Flow Technology

Product Advisories

Product Advisories

Medical Device Correction: HeartMate 3 LVAS Kits  – March 2024

Abbott is notifying customers of complaints of blood leaking out of the left ventricle or air entering the left ventricle or LVAD at the seal interface between the HeartMate 3™ LVAS inflow cannula and the titanium apical cuff. The blood leak or air entrainment has only been observed during the implantation procedure. The letter contains important information when observing blood leaking from the LVAD or air passing into the left ventricle and LVAD. There is no need to return any product to Abbott.

AMERICAS

EUROPE, MIDDLE EAST AND AFRICA

ASIA PACIFIC

Medical Device Correction: HeartMate LVAS Kits and Outflow Grafts – February 2024

Abbott is notifying customers of a planned update to our Instructions for Use associated with observed outflow graft deformation known as “Extrinsic Outflow Graft Obstruction” (EOGO) associated with the HeartMate 3™ Left Ventricular Assist System (LVAS) and HeartMate II™ LVAS. The letter contains important information on how to recognize EOGO and recommended steps to diagnose EOGO. There is no need to return any product to Abbott.

AMERICAS

EUROPE, MIDDLE EAST AND AFRICA

ASIA PACIFIC

Field Safety Notice: HeartMate Touch Communication System – January 2024

A Field Safety Notice was issued on January 3, 2024, indicating that the HeartMate Touch™ Communication System Application Ver. 1.0.32 could result in an unintentional start/stop of the HeartMate 3 Left Ventricular Assist Device (LVAD)

AMERICAS

EUROPE, MIDDLE EAST AND AFRICA

ASIA PACIFIC

Medical Device Correction: HeartMate Touch Communication System — August 2023

Abbott is notifying customers about a single reported event where the HeartMate Touch Communication System connected to an unintended LVAS. This communication is to bring awareness and emphasize existing Instructions for Use.

AMERICAS

ASIA PACIFIC

EUROPE

Medical Device Correction: HeartMate 3 LVAS Kits and Apical Coring Knife — August 2023

Abbott is notifying customers of a finding with the HeartMate Apical Coring Knife provided with the HeartMate 3 Left Ventricular Assist System (LVAS) kits and distributed separately.

AMERICAS

ASIA PACIFIC

EUROPE

Product Advisory Archive

This device is commercially available for use in select international markets.

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POLICIES & ADVISORIES
HEALTHCARE PROFESSIONALS
PATIENTS & CAREGIVERS
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Information contained herein for distribution outside the U.S. only.

CAUTION: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

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