Agency believes “will cause serious adverse health consequences or death”. The U.S. Food and Drug Administration (FDA) this week placed its highest-risk label on a recall of HeartWare International’s circulatory support system because a failed locking mechanism could leave the device without power.
The FDA bumped the recall to Class I, the category reserved for defects the agency believes “will cause serious adverse health consequences or death,” MassDevice.com reports. The recall was initiated on December 6, 2013, but this month HeartWare reissued warnings, reminding doctors that the manufacturing defect could put patients at risk of losing circulatory support.
The recalled products – serial numbers HW001 to HW 11270 and HW20001 to HW 20296 – were manufactured from March 6, 2006 through October 17, 2013 and distributed from March 17, 2006 through November 29, 2013. The HeartWare Ventricular Assist System, the FDA explains, is used as a bridge to a heart transplant in patients who are at risk of death from advanced heart failure. The HeartWare Ventricular Assist System, also known as HeartWare Ventricular Assist Device (HVAD), is designed for use in hospital and out-of-hospital settings, including when transporting patients by air.
Due to faulty manufacturing assembly process, the driveline connector locking mechanism can fail to engage
Because of a faulty manufacturing assembly process, the driveline connector locking mechanism can fail to engage, and, as a result, the pump can stop. This failure could lead to serious adverse health consequences, including death, according to the updated FDA recall notice.
If the driveline becomes disconnected, a “VAD Stopped” (high priority) alarm will alert the patient, who should immediately reconnect the driveline to the controller and contact a doctor or VAD Coordinator. HeartWare will arrange for a permanent repair to the locking mechanism as soon as possible, and advises patients and doctors not to attempt to disconnect or inspect the driveline, which should only be done by a HeartWare clinical engineer.
For questions about recall or to schedule a driveline connector repair, contact HeartWare Clinical Support at 888.494.6365, 24 hours a day, seven days a week, or by email at FSCA@heartware.com. To report adverse events or side effects to the FDA MedWatch Safety Information and Adverse Event Reporting Program, go to www.fda.gov/MedWatch/report.htm.