Thoratec issues urgent medical device correction letter for HeartMate II device

Thoratec voluntarily issued an urgent medical device correction letter on Sept. 16 alerting hospitals to monitor the expiration date of the backup battery contained in the HeartMate II left ventricular assist system device.

The company noted that the backup battery has a 36-month expiration date. At that end of the 36 months, an advisory alarm is activated, although Thoratec said the alarm does not affect the device’s functioning.

Several hospitals notified Thoratec on Sept. 1 that patients had heard the advisory alarm because their backup batteries had expired. Three patients were unable to connect their pump to their backup system controller. Two of the patients died and one sustained a serious injury, according to Thoratec.

In its correction letter, Thoratec said it was “working with hospital staff to identify patients that may be close to reaching the 36-month expiration date of their System Controller backup battery in order to facilitate priority replacement and to ensure routine monitoring of backup battery lifetime during clinic visits, as specified in the product Instructions for Use.”

The HeartMate II is intended for cardiac transplant candidates with advanced heart failure who are at the risk of imminent death from left ventricular failure.

In July, St. Jude Medical agreed to acquire Thoratec for approximately $3.4 billion pending shareholder approval, regulatory approval and other customary closing conditions.