Heartware Ventricular Assist Device Loose Connector

HeartMate II LVAS Pocket System Controller Recall
A Heartware Ventricular Assist Device recall has been announced due to a loose connector that could cause the system to malfunction. These malfunctions could cause the heart pump to stop, resulting in serious injury or death.

Contact an Attorney Today

The nationwide law firm of Bernstein Liebhard LLP is investigating injuries and deaths that may be related to a Heartware Ventricular Assist Device with a loose connector. To learn more about your legal options, please call (888) 994-5118.

Heartware Ventricular Assist Device Recall for Loose Connector

The Heartware Ventricular Assist Device (HVAD) is surgically implanted in patients who require a heart transplant and who are at risk of death due to end stage left ventricular heart failure. The HVAD can be used in or out of the hospital setting, and includes a pump implanted in the space around the heart (pericardium). A driveline connects the pump to external controller, which regulates the function and speed of the pump. The Heartware Ventricular Assist Device can be powered by batteries or powered adapters.

In October 2016, Medtronic announced a recall for HeartWare Controllers due to a power connector problem that could cause the rear portion of the pump’s driveline connector to become separated from the front portion. An expansion of the recall was announced in May 2017.

A Heartware Ventricular Assist Device with a loose connector may allow moisture to enter the HVAD controller, resulting in corrosion, electrical issues, reduced speaker volume and connection failures. The pump may stop­­, resulting in death or other serious complications. The U.S. Food & Drug Administration (FDA) has designated this action a Class I recall, which indicates that use of an HVAD with a loose connector could cause serious or fatal health consequences.

Learn More About Your Legal Options

Individuals who suffered serious complications that may be related to the Heartware Ventricular Assist Device loose connector problem could be entitled to compensation for medical bills, lost wages, pain and suffering, and more. Those who lost a loved one due to such an issue may also be entitled to restitution for wrongful death. To learn more about the legal options available to you, please call (888) 994-5118.

  1. FDA (2016) “HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall – Loose Connectors May Prevent Alarm from Sounding” https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm527148.htm
  2.  FDA (2017) Ventricular Assist Device Controllers and DC Adapter by Medtronic Mechanical Circulatory Support (formerly HeartWare Inc.): Class I Recall – Updated Controller, Power Management Software https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm556762.htm
Last Modified: July 6, 2017

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