|HeartMate II Left Ventricle Assist Device|
Thoratec has been hampered by regulatory woes and market difficulties this year.
Back in April, FDA slapped a Class I recall designation on Thoratec’s Heart Mate II left ventricular assist device. The company initiated the recall less than a month earlier after receiving five reports of serious injury and four reports of death related to difficulty in changing from the primary system controller to a back-up system controller. The device itself wasn’t faulty, but inadequate training materials led to patients and caregivers experiencing difficulties.
In early August, the company’s stock took a deep dive after it missed second-quarter revenue estimates by around $10 million and shipments of the HeartMate line dropped 16%.
The stock recovered later in the year, but CEO Keith Grossman wouldn't provide any details on its ability to hold share in the market in 2015 during a November earnings call. Grossman was president and CEO of the Pleasanton, California company between 2000 and 2006 and was appointed to the helm again in September when the company announced that Gary Burbach has stepped down from his dual roles as board member and CEO.