FDA Warns of Class I Recall for HeartWare VAD Batteries
The US Food and Drug Administration (FDA) is notifying physicians and hospitals of a class I recall of batteries in the HeartWare ventricular assist device (VAD), which is used in patients with end-stage left ventricular heart failure who are awaiting a heart transplant.
The VAD is implanted in the pericardial space and is powered by an external battery pack.
“If the [HeartWare] VAD 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,” according to the FDA.
HeartWare sent an Urgent Medical Device Recall letter to physicians in January 2016 warning that the device could fail because of premature battery failure due to faulty cells. At the time, they asked customers to identify and quarantine affected batteries in the possession of patients and hospitals and to return the products to HeartWare. Hospitals were told to arrange an appointment with qualified company representatives for replacement batteries.
The class I recall affects HVAD batteries with serial numbers BAT000001 to BAT199999 (model number 1650) manufactured and distributed between 2013 and 2015. In total, 18,631 units in the United States have been recalled.
The FDA announcement comes within days of news that Medtronic is moving ahead with the purchase of HeartWare for $1.1 billion. The acquisition is expected to close in October 2016.
Food and Drug Administration. HeartWare ventricular assist device (HVAD) batteries by HeartWare Inc: class I recall – premature power depletion. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm509214.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Published on: June 29, 2016. Accessed on: June 29, 2016.