The FDA issued a Class I recall on a component of the HeartWare Ventricular Assist System. This latest recall targets a splice repair kit that fails when exposed to excessive force.
HeartWare sent letters on May 11 to customers about a splice kit for the HeartWare Ventricular Assist System’s pump driveline. The splice kit is supposed to be used to repair the driveline cable when there is an electrical break in the exit side portion of the driveline.
HeartWare has faced its share of recalls and notices in the past 12 months. Three months ago, it issued a voluntary recall in the U.S. of older ventricular assist system controllers that were distributed during clinical trials. It stated that older, but not newer, controllers are susceptible to electrostatic discharge, which potentially could cause the pump to stop.
A little over a year ago, the FDA issued a Class I recall for the HeartWare Ventricular Assist Device due to a manufacturing flaw. The company reported the locking mechanism in the driveline connector would not properly engage, which potentially could stop the pump from pumping and lead to serious adverse events, including death. The problem was the result of a faulty assembly process.
A few days later, HeartWare issued another voluntary correction notice, cautioning that some batteries might be prone to earlier-than-expected battery depletion.
The most recent recall affects 35 units that had been distributed in Florida, Kentucky, Missouri, New York, Tennessee, Texas, Canada, Germany, Italy, Netherlands, Turkey and the U.K.