HeartWare Model 1101

Reason: Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.

Code information: Serial Numbers: HW1146, HW1205, HW1209, HW1247, HW1454, HW1533, HW1634, HW1688, HW1951, HW200, HW281, HW378, HW383, HW469, HW492, HW557, HW816, HW933, HW1091, HW1143, HW1144, HW1200, HW1242, HW1243, HW1244, HW1276, HW1280, HW1398, HW1403, HW1415, HW1437, HW1439, HW1456, HW1524, HW1553, HW1555, HW1637, HW1694, HW1697, HW1769, HW1816, HW1818, HW1963, HW198, hw209, HW229, HW257, HW290, HW304, HW310, HW321, HW323, HW433, HW467, HW482, HW488, HW536, HW562, HW568, HW578, HW581, HW590, HW591, HW610, HW635, HW645, HW678, HW795, HW796, HW798, HW801, HW819, HW825, HW827, HW888, HW889, HW922, HW978, HW107, HW210, HW216, HW526

Distribution pattern: Worldwide distribution.