Z-0750-2023 Class II Ongoing

HeartWare HVAD Pump Kit, REF MCS1705PU

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.

UDI/DI 008887070090441, Serial Numbers: HW41765, HW42068, HW42069, HW42070, HW42071, HW42081, HW42082, HW42083, HW42176, HW42179, HW42184, HW42195, HW42202, HW42205, HW42261, HW42267, HW42297, HW42298, HW42301, HW42364, HW42368, HW42372, HW42375, HW42379, HW42397, HW42400, HW42401, HW42403, HW42404, HW42405, HW42420, HW42438, HW42439, HW42484, HW42499, HW42522, HW42573, HW42581, HW42582, HW42585, HW42586, HW42591, HW42595, HW42596, HW42610, HW42611, HW42612, HW42614, HW42615, HW42618, HW42681, HW42685, HW42691, HW42692, HW42693, HW42694, HW42695, HW42696, HW42697, HW42699, HW42701, HW42704, HW42705, HW42706, HW42713, HW42826, HW42832, HW42839, HW42845, HW42846, HW42847, HW42853, HW42924, HW42925, HW42929, HW42930, HW42934, HW42935, HW42936, HW42945, HW42946, HW42950, HW42951, HW42954, HW42956, HW42957, HW42958, HW42959, HW42963, HW42972, HW42975, HW42977, HW42978, HW42979, HW42980, HW42982, HW42984, HW42985, HW42986, HW43015, HW43019, HW43027, HW43032, HW43037, HW43038, HW43039, HW43040, HW43042, HW43044, HW43047, HW43048, HW43052, HW43053, HW43054, HW43062, HW43064, HW43109, HW43114, HW43115, HW43116, HW43125, HW43157, HW43187, HW43188, HW43197, HW43219, HW43240, HW43247, HW43248, HW43249, HW43251, HW43253, HW43255, HW43257, HW43258, HW43262, HW43268, HW43270, HW43276, HW43313, HW43316, HW43322, HW43352, HW43366, HW43453, HW43489