Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Reason for recall: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components Distribution: Worldwide Quantity: 892 units Lot/code info: Serial numbers: HW1000, HW1001, HW1002, HW1003, HW1006, HW1007, HW1008, HW1010, HW1011, HW1013, HW1017, HW1018, HW1019, HW1026, HW1027, HW1029, HW1030, HW1034, HW1035, HW1037, HW1038, HW1040, HW1044, HW1053, HW1054, HW1055, HW1056, HW1057, HW1058, HW1059, HW1061, HW1062, HW1063, HW1064, HW1065, HW1066, HW1067, HW1068, HW1076, HW1078, HW1093, HW1094, HW1095, HW1096, HW1097, HW1099, HW1100, HW1101, HW1102, HW1103, HW1104, HW1106, HW1107, HW1108, HW1109, HW1110, HW1112, HW1114, HW1115, HW1116, HW1117, HW1118, HW1119, HW1125, HW1126, HW1127, HW1128, HW1129, HW1130, HW1131, HW1132, HW1133, HW1134, HW1135, HW1136, HW1149, HW1150, HW1151, HW1152, HW1153, HW1154, HW1156, HW1158, HW1160, HW1161, HW1162, HW1163, HW1164, HW1165, HW1166, HW1167, HW1168, HW1169, HW1170, HW1172, HW1173, HW1174, HW1175, HW1176, HW1178, HW1179, HW1180, HW1181, HW1182, HW1186, HW1187, HW1188, HW1189, HW1190, HW1191, HW1192, HW1193, HW1195, HW1196, HW1198, HW1199, HW1212, HW1213, HW1214, HW1215, HW1216, HW1217, HW1218, HW1219, HW1220, HW1221, HW1223, HW1225, HW1226, HW1228, HW1231, HW1233, HW1234, HW1235, HW1236, HW1255, HW1256, HW1260, HW1270, HW1271, HW1272, HW1274, HW1275, hw1279, HW1285, HW1286, HW1287, HW1288, HW1289, HW1290, HW1291, HW1294, HW1295, HW1296, HW1298, HW1299, HW1302, HW1303, HW1304, HW1312, HW1313, HW1314, HW1315, HW1316, HW1317, HW1318, HW1344, HW1346, HW1347, HW1348, HW1349, HW1350, HW1351, HW1352, HW1353, HW1355, HW1357, HW1360, HW1361, HW1362, HW1363, HW1364, HW1365, HW1368, HW1369, HW13
Official record: FDA (Device enforcement) ↗
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