HeartWare International Recalls Older Clinical Trial Controllers

HeartWare International Inc. is voluntarily recalling its older HeartWare Ventricular Assist System Controllers, warning the product has a higher chance of malfunctioning than its newer counterpart. The company claims the older models have a better chance of leading to electrostatic discharge (ESD), which ultimately can cause serious injuries or even death.

Affected controllers demonstrated a 4 percent ESD event rate probability after 12 months of use, compared with a 0.1 percent ESD probability for newer controllers. The affected models (product codes 1400 and 1401XX) were distributed throughout the United States during the Advance and Endurance clinical trials before receiving U.S. Food and Drug Administration (FDA) approval in 2012, according to the company. The clinical trials have Serial Numbers CON000001 through CON005472; HeartWare estimates the recall impacts approximately 120 U.S. patients.

Company executives claim the recall pertains to a previously known issue, and really is a continuation and expansion of a voluntary Field Safety Correction Action undertaken in 2013. As part of the 2013 Notice, HeartWare provided information to help clinicians and patients monitor controller performance and reduce the potential for an ESD event, which is a known risk for electronic equipment. As stated in the 2013 Notice, patients can reduce the risk of ESD by avoiding dry environments, certain fabrics and materials such as silk clothing and carpeting, electronic devices prone to static electricity and certain activities such as vacuuming and removing clothes from a dryer. Since the 2013 Notice, HeartWare has received reports of one additional death and one additional serious injury in which ESD may have caused or contributed to a pump stop.

Clinicians are being asked to identify patients with recalled controllers, review the applicable risks with the patient and, if medically advisable, exchange the recalled controllers under medical supervision with a new controller (serial number CON005473 or higher). Treating physician’s must assess a patient’s status and determine if the related risks are acceptable, HeartWare noted in a news release. The company asks that patients not exchange recalled controllers because controller exchanges may not be suitable for all patients. Rather, recalled controller exchanges should be performed in a controlled setting under medical supervision.

Patients with questions about this announcement should contact their physician or VAD Coordinator at their hospital center.  Clinicians who wish to return affected product or with questions should contact their HeartWare representative.

HeartWare has advised FDA of this action. Adverse reactions or quality problems experienced with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Based in Framingham, Mass., HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat patients suffering from advanced heart failure.