This article is more than 5 years old. Information may no longer be current.

FDA designates recall of left ventricular assist device controller as Class 1

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

The FDA has designated Abbott/Thoratec’s product recall of a power supply for a left ventricular assist device pump as a Class 1 recall, the most serious kind.

The recall affects 28,882 devices that were manufactured and distributed between July 2012 and March 2017 in the United States.

The company received 70 incident reports, including 19 injuries and 26 deaths caused by an improper or slow driveline changeover of the backup system controller (HeartMate II LVAS Pocket System Controller) for the LVAD pump (HeartMate II LVAS pump). Deaths occurred while patients exchanged controllers away from a hospital. Those who are elderly or untrained are at increased risk for device malfunction when controllers are exchanged, the FDA stated.

In March 2017, the company sent a letter to affected patients and clinicians, informing them of the recall and upgraded software and hardware to assist in the changeover process in emergency scenarios.