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| Thoratec's HeartMate II left ventricular assist device--Courtesy of Thoratec |
Thoratec's ($THOR) problems involving a backup power device used with its HeartMate pumps have gotten substantially worse. A formal recall of the product is now in place, and the FDA slapped a Class I status on the effort, its most serious designation, which means the issue can result in serious injury or death.
Regulators are concerned about Thoratec's HeartMate II Left Ventricular Assist Pocket System Controller, which helps supply power to the implanted HeartMate II left ventricular assist implantable heart pump. The company provides a backup system controller (battery-powered) in case the main device malfunctions or an external battery pack runs low, and patients get instructions and training on how to switch from one system to another.
In early March, Thoratec issued a safety advisory and commenced with a recall for the Pocket System Controller after problems erupted with some patients who struggled to switch from the primary system controller to the backup. Four patients died after having problems making the switch, and 5 others faced serious injury, the FDA said.
Each affected patient had previously used an older controller model, the FDA said, noting that the design differences between the older, EPS System Controller and the new Pocket System Controller mandated a different approach to how it was connected to the main HeartMate II device, or the controller wouldn't work. Patients didn't get extensive training on how to use the new model, the FDA said.
The FDA noted that the company informed patients and doctors about the issue, warning physicians that they need to review labeling and training materials relating to the Pocket System Controller. Additionally, Thoratec said it plans to update labeling and training materials to better instruct patients on how to connect their implant to the Pocket System controller.
For California-based Thoratec, this is an issue that could hurt big. Thoratec has relied heavily on its HeartMate pumps for much of its recent growth, and unless there is a quick resolution, the company's rapid revenue growth, which has been slowing, could come to an abrupt end.
- read the FDA recall notice