HeartWare Recalls Clinical Trial Ventricular Assist System ControllersFeb 27, 2015
Older versions of HeartWare's Ventricular Assist System Controllers are being recalled in the United States. The recall, which is an extension of an earlier field action, has been issued in other countries as well over the past few weeks. The affected devices are more likely to undergo an electrostatic discharge (ESD); this can cause a pump stop and lead to serious injury or death. Over the past few weeks, the recall has also been initiated in other countries.
The U.S. Food and Drug Administration (FDA) approved the devices in 2012. The recalled controllers were distributed before this time, during the clinical trial period. Because significant design improvements were made, later models are not affected.
Physicians should determine which patients have the trial controllers and subsequently analyze the risks. The company says that if medically advisable, the recalled controller should be replaced with a new one.
In 2013, the company issued a voluntary Field Safety Corrective Action, FSCA APR2013. This recall expands on that action and affects nearly 120 patients in the U.S., HeartWare says. The 2013 notice said that patients can lower the risk of an ESD event by avoiding dry environments as well as materials prone to static electricity such as silk clothing and carpeting. Patients affected by the recall should also avoid activities such as vacuuming and removing clothes from a dryer. Ever since the notice issued in 2013, the company received reports of one additional death and one injury as a result of an ESD event.