Medical Device Maker HeartWare Acknowledges Receipt of FDA Warning Letter

HeartWare International, Inc., a medical device maker based in Framingham, Massachusetts, announced that on June 3, 2014 it received a warning letter from the U.S. Food and Drug Administration (FDA). The letter is the result of a January 2014 inspection of the company’s facility in Miami Lakes, Florida.

According to a company press release, reported by the Wall Street Journal, the FDA letter cites four categories the company needs to address: procedures for validating device design, including device labeling; procedures for implementing corrective and preventive action (CAPA); maintaining records related to investigations; and validation of computer software used as part of production or quality systems. The letter does not require any action by physicians or patients and does not restrict the use of HeartWare devices.  

HeartWare said it will respond to the letter within the required 15 days, and the company said it expects to implement new and enhanced systems and procedures. The FDA explains that a warning letter is issued for violations of “regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected.”

HeartWare International manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat patients suffering from advanced heart failure. The HeartWare Ventricular Assist System features the HVAD pump, which can be implanted next to the heart. The HeartWare System is approved for use as a bridge to a heart transplant in patients at risk of death from refractory end-stage left ventricular heart failure. Some HVAD devices are under an FDA Class I recall because the driveline connector locking mechanism can fail to engage, and, as a result, the pump can stop. Pump failure could lead to serious adverse health consequences, including death, according to the FDA recall notice.