The FDA today released a recall notice for Medtronic (NYSE:MDT) subsidiary HeartWare International‘s Heartware Ventricular Assist Device over issues with driveline connector tubes of select units which may cause the pump to stop.
The federal watchdog labeled the recall as Class 1, indicating “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.
The company’s HVAD system is designed to deliver blood from the heart to the rest of the body, for use in patients who are at risk of death from end-stage left ventricular heart failure, or patients waiting for a heart transplant.
The recall is over a design problem with select driveline connectors, which connect the HVAD’s pump to the external controller and power source. The design flaw with the driveline connector may cause fluid or other material to enter the pump and cause electrical issues or pump stoppage, according to the Agency.
Electrical issues and pump stops could result in serious adverse health consequences, including death, according to an FDA release.
All HVAD serial numbers lower than HW25838 with product codes 1103 and 1104 are affected by the recall, manufactured between March 17, 2006 and June 27, 2016. A total of 105 units distributed within the U.S. are being recalled.
The company instructed affected customers to identify the pumps in inventory and return them, as well as reminding patients of safe use procedures with the devices.