Thoratec Issues Voluntary Device Correction for the HeartMate II
Thoratec Corporation issued an urgent Medical Device Correction Letter to all hospitals who have patients supported with the HeartMate II “Pocket” System Controller.
About the Medical Device Correction Letter
According to the U.S. Food and Drug Administration (FDA), the letter Thoratec sent out to hospitals is intended to remind them to monitor the expiration date of the backup battery contained within the HeartMate II “Pocket” System Controller, as described in the products instructions.
The backup battery lasts for 36 months. At the time of expiration, an advisory alarm sounds, and a yellow wrench symbol appears. This occurs on the first day of whatever month the battery is suppose to expire. These warnings DO NOT affect the function of the device.
On September 1, 2015 Thoratec received several reports about a number of patients who encountered the advisory alarm. Some patients tried to switch from their primary to backup system controller. Three patients were unable to connect their pump to their backup system in time, resulting in one serious injury and two deaths.
What if you are a HeartMate II LVAS Patient?
- If the serial number on your system controller starts with EPC you are not affected by this situation.
- If the serial number on your system controller starts with PC and you received the device more than two years ago, please contact your doctor immediately in order to have the expiration date checked and possibly replaced.
- If the serial number on your system controller starts with PC and you received the device less than two years ago, be sure to ask your doctor to check the battery at each visit.
- Patients with questions or are experiencing this issue should contact their doctor or VAD coordinator.