Thoratec Issues Voluntary Correction Letter for HeartMate II LVAS
Thoratec has issued a voluntary Urgent Medical Device Correction Letter to all hospitals that have patients supported with the HeartMate II LVAS, a first-line intermediate-to-chronic left ventricular assist device.
The letter reminds hospitals to monitor the expiration date of the backup battery within the pocket system controller in the device.
The company has received reports from hospitals this month of patients experiencing advisory alarms for expired backup batteries. The batteries have a 36-month expiration date, although exceeding the date does not affect the function of the device.
Headquartered in Pleasanton, Calif., Thoratec focuses on developing therapies to address advanced-stage heart failure. — Michael Cipriano