FDA Recalls Older HeartWare Controllers
The U.S. Food and Drug Administration (FDA) reports that HeartWare International, Inc. has issued a recall for the older HeartWare Ventricular Assist System Controllers, used in the ADVANCE and ENDURANCE clinical trials in 2012. According to the company, the older devices “exhibit a higher susceptibility to electrostatic discharge (ESD) than newer [ones],” which could cause a pump stop in the device. HeartWare urges clinicians to identify patients with the recalled controllers and take further steps to mitigate their risk of a pump stop.
Read the FDA’s recall announcement for more information on device serial numbers and other warnings.
Clinical Topics: Sleep Apnea
Keywords: Mental Recall, Product Surveillance, Postmarketing, Risk, United States Food and Drug Administration
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