MASSDEVICE ON CALL — The FDA this week put its highest-risk label on a recall of HeartWare International’s (NSDQ:HTWR) circulatory support system over concerns about failed locking mechanisms that could leave the implants without power.
The FDA gave the recall, initiated in December 2013, a Class I classification, reserved for defects that the agency believes "will cause serious adverse health consequences or death."
HeartWare reissued warnings this month remind doctors of the manufacturing defect, which puts patients at risk of losing circulatory support.
The company has already received 8 complaints of failed locking mechanisms in the patient driveline connectors, which connect the implanted circulatory assist device to an external controller that powers and monitors the device. In half of those cases, the disconnected driveline connector resulted in a temporary stop in pumping therapy, which HeartWare said "could cause serious injury or death, depending on the function of a patient’s native heart."
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