Medical Device Safety and Recalls: Abbott-Thoratec Recalls HeartMate II LVAS Pocket System Controller Due to Risk of Patient Injury and/or Death during Backup Controller Exchange

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Abbott-Thoratec Recalls HeartMate II LVAS Pocket System Controller Due to Risk of Patient Injury and/or Death during Backup Controller Exchange

Patients may sometimes need to change to their backup back-up system controller during the course of ventricular assist therapy. The change should be done quickly and in the hospital, because it can present a significant challenge to patients that are elderly and/or untrained. For these patients, a slow or improper driveline changeover places them at risk of serious injury or death.

Abbott-Thoratec has received a total of 70 reports of incidents in which the controller has malfunctioned after an exchange, including 19 injuries and 26 deaths. All of the deaths occurred when patients attempted to exchange controllers while away from the hospital.

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.

---

Subscriber Services:
Manage Preferences  |  Unsubscribe  |  Help with this service

Stay Connected:

Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received by taking our Customer Service Survey.

---

This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 1-888-INFO-FDA (1-888-463-6332)