Framingham, Mass.-based HeartWare said the warning letter flagged 4 observations logged during an inspection of the Miami Lakes facility in January.
HeartWare said the federal watchdog agency wants it to address its procedures for validating device design, including device labeling; procedures for implementing corrective and preventive action; maintaining records related to investigations; and validation of computer software used as part of production or quality systems.
"HeartWare is committed to providing the highest quality products in compliance with FDA regulations to ensure the safety and welfare of patients who rely on our devices, and we are dedicating the resources necessary to address the items discussed in the letter," president & CEO Doug Godshall said in prepared remarks.
The medical device company said it will respond to the warning letter within the 15-day window set by the FDA.
"The company expects to implement new and enhanced systems and procedures, and will perform additional actions as may be required to resolve the issues raised in the FDA communication," according to a regulatory filing. "The letter issued by FDA does not require any action by physicians or patients and does not restrict use of HeartWare’s devices."
The FDA has not yet released the warning letter.
In April HeartWare reiterated a warning about failed locking mechanisms in the patient driveline connectors on its left ventricular assist device, an implantable heart pump. 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."
None of the patients associated with the 8 complaints were injured, HeartWare said.