The HeartWare Ventricular Assist Device (HVAD), also known as the HeartWare Ventricular Assist System, was approved by the FDA in 2012 as a bridge treatment for those awaiting heart transplants. The HVAD is produced by HeartWare Inc and has been used by more than 5000 people.
On April 29, 2014, the U.S. Food and Drug Administration (FDA) announced a Class I recall for HeartWare Ventricular Assist Systems manufactured between March 2006 and October 2013.
The FDA warns that driveline connector locking mechanism was manufactured incorrectly, causing failure to engage. This can prevent the HeartWare Ventricular Assist Device from functioning and leading to death and other serious adverse events.
The FDA issues Class 1 recalls when the use of a product has a reasonable probability of death or serious adverse effects.
The recalled catalog and serial numbers for the HeartWare Ventricular Assist System are:
Medical Device Network continues by reporting that three deaths were reported, between January 2011 and March 2014, which are potentially related to the battery issue.
Cardiovascular Business reports the batteries with product codes 1650 and 1650-DE are the batteries HeartWare is warning could be subject to early depletion.
On June 2, 2014, the FDA sent a warning letter to HeartWare about failure to follow proper manufacturing and follow up procedures. The letter is in response to an FDA inspection of the HeartWare manufacturing plant in Miami Lakes, Florida.
Worcester Business Journal reports the letter from the FDA accuses HeartWare of failing to ensure the effectiveness of corrective actions, failing to keep proper records, and failing to follow proper procedures. The FDA warns that HeartWare failed to have proper corrective procedures in place for the following issues:
The FDA gave HeartWare fifteen days to respond to the warning letter with the specific steps and actions that the company plans to follow to ensure the issues are corrected and to prevent the future recurrence of similar issues.