HeartWare Gets FDA Warning Letter

June 4, 2014 — Six months after recalling a device for manufacturing problems, HeartWare International Inc. says it has received a warning letter from the U.S. Food and Drug Administration (FDA) after inspectors found problems at manufacturing facilities in Florida.

According to the company, the FDA cited four areas that need to be addressed:

• Procedures for validating device design, including labeling
• Procedures for implementing corrective and preventative action
• Maintaining records related to investigations
• Validation of computer software used as part of production or quality systems

The warning letter does not restrict use of the company’s devices. HeartWare says it takes the matter seriously and will respond within 15 days and expects to implement new and enhanced systems as required to address the FDA concerns.

HeartWare International manufactures the HeartWare Ventricular Assist Device (HVAD), an implanted left-side heart pump that continuously pushes blood through the heart. It is used as a “bridge to transplant” for patients with end-stage heart failure.

On May 1, HeartWare warned that the batteries on the HVAD could deplete earlier than expected. They said they would replace any fully charged batteries that last less than two hours. At the time, they said no deaths were caused by faulty batteries. However, at least three deaths were possibly linked to power source problems.

In December 2013, HeartWare recalled the HVAD and the FDA classified the recall as Class I. The recall was issued because a faulty manufacturing process caused the driveline connector locking mechanism to fail to engage. This could result in the pump stopping unexpectedly.

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