FDA puts Class I recall on HeartWare device

The FDA issued a Class I recall for the HeartWare Ventricular Assist Device (VAD) due to a manufacturing flaw.

HeartWare International has received reports that 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.

The FDA advised physicians to follow up with patients implanted with the device, which was approved in the U.S. in November 2012 as a bridge-to-transplant therapy for patients with advanced heart failure. Physicians should inspect the drive connector and report any adverse events to the FDA.

The VAD is also known as the HeartWare Ventricular Assist System. Affected devices are under catalog numbers 1100, 1101, 1102, 1103, 1104, and 1205 and serial numbers HW001 to HW 11270 and HW20001 to HW 20296. The devices were manufactured between March 6, 2006, and Oct. 17, 2013, and distributed from March 17, 2006, through Nov. 29, 2013.

The Framingham, Mass.-based company said it issued a correction in December 2013 alerting healthcare providers after it received eight reports of the locking mechanism failing to engage. In four cases, the pump temporarily stopped but none of the incidents led to patient injury.

According to the company, almost 4,000 patients worldwide have been treated with the device, which has been approved in Europe and Australia as well.