HeartWare’s Ventricular Assist System Recall gets Highest-Risk Class I Label

HeartWare-Ventricular-Assist-SystemHeartWare International’s recall of their Ventricular Assist System, also known as the HeartWare Ventricular Assist Device (HVAD) has been classified as Class I by the U.S. Food and Drug Administration (FDA). The Class I designation is the agency’s most serious warning; it means that there is a reasonable risk of serious injury or death associated with exposure to the device.  The system was recalled in December due to a failed locking mechanism. Last week, the company issued a reminder about the defect, citing 8 reports where the locking mechanism failed to engage.

HeartWare issued a news release last Thursday reminding patients and healthcare professionals about the driveline connector defect in its HVAD. The release mentioned 8 reports where the locking mechanism failed in the circulatory support system. In four of these cases, the failed locking mechanism caused the pump to temporarily stop. This “could cause serious injury or death, depending on the function of a patient’s native heart” the company said. Patients are asked to discuss the device issue with their physicians or VAD Coordinator. HeartWare reiterated that clinicians should inspect the driveline connector at each clinic visit to ensure that there is proper locking.

The original recall notification was issued on December 6, 2013. According to the notification, the ventricular assist system is used as a bridge to cardiac transplantation in patients who are risk of dying from advanced heart failure. The system has both internal and external parts, including an internal pump, external controller, power sources and the driveline that connects the pump to the controller. The system can be used for both in-hospitals and out-of-hospitals settings, including situations where patients need to be transported by an aircraft. A recall was issued because of a defect that can cause the locking mechanism to fail in the driveline connectors. This defect was “a result of a faulty manufacturing assembly process” and “could result in the pump stopping and potentially lead to serious adverse health consequences, including death” the notice read.

The recall notice says that if the driveline becomes disconnected from the patient controller, then a “VAD stopped” alarm will sound. If this happens, then the driveline should be immediately reconnected to the controller as instructed in the patient manual and the patient should contact their doctor of VAD Coordinator immediately.

The systems were manufactured between March 6, 2006 and October 17, 2013 and distributed from March 17, 2006 and November 29, 2013. An Urgent Device Medical Device Correction letter was sent to customers on December 12, 2013.

This entry was posted in Legal News. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.