MASSDEVICE ON CALL — The FDA issued it’s highest-risk Class I warning after Thoratec (NSDQ:THOR) recalled its HeartMate II implantable heart pumps over a controller issue that the FDA said was associated 4 patient deaths and 5 serious injuries.
Thoratec initiated the recall early last month, affecting devices distributed from August 2012 through this year, according to the FDA notice.
The patient injury reports were tied to instances in which the patients attempted to swap their HeartMate II LVAS devices from an older controller to the Pocket System Controller.
"These patients did not receive intensive training on connecting the new controller," according to the warning. "The design differences between the EPC System Controller and the Pocket System Controller require a different approach to how the device is connected. If the controller is not properly connected, the device cannot function."
The HeartMate II LVAS devices rely on the controllers to help power the implant, which helps circulate blood throughout the body, taking the load off the heart which may be too weak to circulate blood on its own. The defects arose when patients attempted to switch to a newer controller that became available more recently.
Thoratec plans to update its labeling and training materials and has asked patients to undergo new training on use of their devices.
Medtronic makes progress toward the artificial pancreas
Medtronic (NYSE:MDT) chief medical officer Dr. Francine Kaufman details the company’s work on the MiniMed 530G with Enlite, bringing health care closer to a so-called "artificial pancreas" system.
Peer inside Philips Healthcare’s prototype lab
Philips Healthcare (NYSE:PHG) opened the doors to its rapid prototyping lab, where the company churns out a variety of medical devices in just a couple of weeks.
Nerve repair after spinal cord injury?
Researchers from Imperial College London present new research that suggests clinicians may one day be able to use chemicals to repair nerves following spinal cord injury or brain trauma.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.