Bad news for Thoratec Corporation ! The U.S. Food and Drug Administration (FDA) slapped its highest level Class I warning on the company’s recent recall of HeartMate II implantable heart pumps due to a problem with their Pocket System Controllers. Class I warning indicates that the problem can lead to fatal injury.
THOR initiated its recall of HeartMate II left ventricular assist device (LVAD) after sending safety advisory to hospitals regarding the use of its pocket system controller for the device. The Pleasanton, CA-based company received reports of four deaths and five patient injuries happened while switching from primary system controllers to backup system controllers.
HeartMate II is implanted in patients with advanced heart failure that helps heart pump blood. It is connected to an external battery pack and a system controller, which alarms patients if the battery runs down.
THOR started selling new Pocket System Controllers for the device in Aug 2012 in Europe and in May 2013 in the U.S. It has been prescribed to 2,142 patients since Aug 2012. However, the new system Pocket System Controller is different from the old EPC System Controller used previously for the device.
THOR revealed that four patients died while struggling to change their controller themselves while five others lost consciousness or suffered decreased blood flow due to difficulty in switching controllers.
FDA revealed that the deaths and injuries happened due to lack of extensive training as the new Pocket System Controller requires a different approach for connecting with the device. If the controller is improperly connected, the device could malfunction.
FDA noted that THOR has already advised all the patients and physicians regarding the problem. The federal watchdog agency acknowledged the fact that THOR decided to retrain the patients and their caregivers for using the new controller as well as update the labeling with better instruction.
HeartMate II is a flagship product of THOR and the company relies heavily on it for generating revenues. As a result, getting a Class I recall notice for such a product could significantly hurt the company’s earnings.
Currently, THOR retains a Zacks Rank #3 (Hold). Some better-ranked stocks in the medical instruments sector include Cynosure, Inc. , Syneron Medical Ltd. , and ArthroCare Corporation . Both Cynosure and Syneron Medical sport a Zacks Rank #1 (Strong Buy), while ArthroCare retains a Zacks Rank #2 (Buy).