FDA Recalls around 30,000 Abbott-Thoratec’s HeartMate II LVAS Devices
The FDA issued a Class I Recall against HeartMate II Left Ventricle Assist (LVAS) Pocket System Controller manufacturer, Abbott-Thoratec. This is the most serious formal recall since the issue with the device can result in serious injury or death. Regulators are concerned that when switching to the backup system the device can malfunction and thus gravely injuring the patient.
About HeartMate II LVAS
The Abbott-Thoratec’s HeartMate II LVAS is a heart pump device to help patients awaiting heart transplants. The $100,000 system enables blood delivery from the dysfunctional left ventricle of the patient’s heart to the body. It helps generate blood flows up to 10 liters per minute. Doctors implant the system in the abdomen, and a connector brings blood from the pump to the aorta.
In an earlier version of the device, the manufacturer designed the bend relief and outflow graft to attach to the pump. However, early last year, Abbott-Thoratec released the new version. It now comes with a detachable release to help surgeons to more easily remove air from the graft. Currently, HeartMate is the only product on the market for heart-failure patients.
Thousands of people depend on this system to save their lives. Unfortunately, it can lead to a multitude of injuries and complications. Patients may sometimes need to change to their backup system controller during the course of ventricular assist therapy. The change should be done quickly and in the hospital. This is because the backup change is a significant challenge to patients that are elderly or untrained. For these patients, a slow or improper driveline changeover places them at risk of serious injury or death.
As a result, Abbott-Thoratec has received 70 reports of incidents in which the controller has malfunctioned after an exchange, including 19 injuries and 26 deaths.
To address this issue, Abbott-Thoratec is providing all HeartMate II LVAS with Pocket Controller users with new software and hardware updates to assist patients in successfully changing their pocket controller in emergency situations.
This isn’t the first time the FDA recalled this device. The previous recall happened after nearly 30 reports of the heart pump not being connected correctly. In five cases, patients needed additional surgery, and one patient died.
HeartMate Class I Recall
A recall means a medical device is defective, and it could lead to serious harm or death. A Class I Recall is the most severe. The model numbers listed in the recall are 105109, 106015, 106762, and 107801. To address the issue of device malfunctions occurring while using the backup system, Abbott-Thoratec is providing all HeartMate II LVAS with Pocket Controller users with new software and hardware updates.
Furthermore, the manufacturing dates in question are between July 2012 and December 2016 and were on the market between July 2012 and March 2017. There are an estimated almost 30,000 devices involved in the recall.
Therefore, if Abbott-Thoratec’s HeartMate II Left Ventricle Assist System injured you, you need a law firm with decades of experience going against large corporations. The Michael Brady Lynch Firm will take whatever legal measures are necessary when fighting for your rights to damages.