HeartWare voluntarily recalled batteries for its HeartWare ventricular assist device (HVAD) on June 29 after discovering the batteries may lose power prematurely due to faulty cells.
The announcement of the recall occurred two days after Medtronic agreed to acquire HeartWare for approximately $1.1 billion. Medtronic said it would purchase HeartWare’s outstanding shares at $58 per share, a more than 90 percent premium from the company’s share price before the deal was announced.
The company recalled 18,631 units in the U.S. that were manufactured from May 19, 2013, to July 1, 2015, and distributed from May 21, 2013, to July 31, 2015. The serial numbers were BAT000001 to BAT199999, and the model number was 1650.
“If the HVAD system is not connected to an additional power source shortly after the system sounds an alarm indicating a low battery level, the pump will stop working and the patient may experience serious adverse health consequences, including death,” the FDA said in a statement.
This is the latest recall of the HeartWare device, which has been plagued with issues for the past few years. However, Medtronic said that acquiring HeartWare would help it expand its heart failure business.
Although the FDA announced the recall on June 29, the agency noted that HeartWare sent a recall letter to affected customers on January 7. The company said the recall might affect patients using the HVAD system with defective batteries and healthcare providers and caregivers monitoring those patients.