FDA Enforcement Class II Ongoing

HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102

Recall: Z-0477-2024 · Reported December 13, 2023

Enforcement

Recall Number: Z-0477-2024
Event ID: 93405
Classification: Class II
Status: Ongoing
Product Type: Devices
Firm: Heartware, Inc.
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Report Date: December 13, 2023
Initiation Date: October 31, 2023
Classification Date: December 1, 2023
Address: 14400 Nw 60th Ave, Miami Lakes, FL, 33014-2807, United States

Description

Reason

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

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, HW1370, HW1371, HW1372, hw1373, HW1402, HW1405, HW1406, HW1407, HW1408, HW1409, HW1418, HW1419, HW1422, HW1423, HW1424, HW1438, HW1442, HW1443, HW1444, HW1445, HW1446, HW1448, HW1450, HW1453, HW1455, HW1458, HW1459, HW1463, HW1464, HW1468, HW1469, HW1470, HW1471, HW1473, HW1474, HW1475, HW1476, HW1477, HW1478, HW1479, HW1480, HW1481, HW1482, HW1483, HW1484, HW1485, hw1486, hw1487, HW1489, HW1491, HW1492, HW1497, HW1498, HW1499, HW1501, HW1502, HW1503, hw1506, HW1507, HW1508, HW1509, HW1511, HW1513, HW1514, HW1515, HW1516, HW1520, HW1522, HW1525, HW1526, HW1527, HW1530, HW1536, HW1537, HW1538, HW1539, HW1540, HW1542, HW1544, HW1545, HW1546, HW1547, hw1549, HW1550, HW1551, HW1552, HW1558, HW1560, HW1561, HW1563, HW1566, HW1567, HW1568, HW1569, HW1570, HW1571, HW1575, HW1579, HW1580, HW1581, HW1582, HW1583, HW1585, HW1586, HW1587, HW1588, HW1590, HW1591, HW1592, HW1594, HW1595, HW1596, HW1597, HW1600, HW1601, HW1602, HW1603, HW1604, HW1605, HW1607, HW1609, HW1610, HW1611, HW1614, HW1615, HW1616, HW1617, HW1619, HW1620, HW1621, HW1624, HW1625, HW1626, HW1631, HW1639, HW1643, HW1644, HW1645, HW1646, HW1647, HW1648, HW1649, HW1650, HW1651, HW1652, HW1653, HW1654, HW1655, HW1656, HW1657, HW1658, HW1659, HW1660, HW1665, HW1666, HW1667, HW1669, HW1670, HW1671, HW1672, HW1674, HW1675, HW1676, HW1678, HW1679, HW1680, HW1683, HW1685, HW1686, HW1700, HW1703, HW1704, HW1705, HW1707, HW1710, HW1711, HW1712, HW1713, HW1714, HW1715, HW1717, HW1719, HW1720, HW1721, HW1731, HW1736, HW1738, HW1739, HW1742, HW1749, HW1751, HW1752, HW1755, HW1756, HW1779, HW1780, HW1781, HW1782, HW1784, HW1786, HW1787, HW1788, HW1789, HW1791, hw1793, HW1795, HW1797, HW1798, HW1799, HW1800, HW1802, HW1806, HW1807, HW1809, HW1814, HW1829, HW1833, HW1834, HW1835, HW1836, HW1837, HW1838, HW1840, HW1842, HW1846, HW1847, HW1849, HW1854, HW1860, HW1861, HW1863, HW1866, HW1867, HW1868, HW1871, HW1875, HW1880, HW1909, HW1910, HW1911, HW1916, HW1918, HW1932, HW1945, HW1946, HW1948, HW1949, HW1953, HW1954, HW1956, HW1957, HW1958, HW1959, HW1975, HW1980, HW1981, HW1982, HW1984, HW1985, HW1986, HW1988, HW1989, HW1990, HW1991, HW1992, HW1993, HW1994, HW1995, HW2020, HW2021, HW2022, HW2024, HW2025, HW234, HW237, HW238, HW241, HW243, HW244, HW245, HW246, HW248, HW265, HW267, HW268, HW271, HW272, HW273, HW275, HW276, HW283, HW287, HW288, HW289, hw291, HW293, HW294, HW295, HW301, HW302, HW306, HW307, HW308, HW309, HW311, HW312, HW318, HW326, HW327, HW332, HW333, HW334, HW340, HW341, HW342, HW343, HW349, HW350, HW352, HW354, HW355, HW356, HW357, HW358, HW359, HW360, HW361, HW362, HW364, HW365, HW367, HW368, HW370, HW372, HW373, HW374, HW375, HW376, HW386, HW388, HW389, HW391, hw393, HW394, HW396, HW407, HW408, HW411, HW412, HW413, HW414, HW423, HW424, HW432, HW434, HW435, HW437, HW438, HW439, HW445, HW448, HW449, HW451, HW453, HW457, HW458, HW459, HW460, HW461, HW462, HW463, HW464, hw465, HW470, HW471, HW472, HW473, HW476, HW477, HW480, HW483, HW485, HW487, HW489, HW491, HW493, HW495, HW496, HW499, HW502, HW503, HW504, HW507, HW508, HW509, HW510, HW511, HW512, HW513, HW514, hw515, HW516, HW517, HW518, HW519, HW520, HW521, HW522, HW523, HW524, HW537, HW538, HW539, hw540, HW541, HW542, HW543, HW544, HW545, HW546, HW547, HW548, HW549, HW550, hw551, hw552, HW553, HW554, HW558, HW559, HW565, HW569, HW570, hw571, HW572, HW573, HW574, HW576, HW579, HW580, HW582, HW586, HW587, HW588, HW589, HW593, HW594, HW595, HW596, HW597, HW598, HW599, HW604, HW606, HW607, HW611, HW612, HW613, HW614, HW615, HW616, HW617, HW618, HW619, HW621, HW624, HW625, HW630, HW631, HW632, HW634, HW637, HW639, HW641, HW647, HW649, HW651, HW652, HW653, HW654, HW655, HW656, HW657, HW664, HW665, HW666, HW667, HW668, HW669, HW671, HW673, HW674, HW675, HW676, HW679, HW681, HW682, HW684, HW685, HW686, HW687, HW688, HW689, HW690, HW695, HW696, HW697, HW698, HW699, HW700, HW701, HW703, HW704, HW705, HW707, HW708, HW709, HW710, HW711, HW712, HW713, HW714, HW715, HW716, HW717, HW718, HW719, HW720, HW721, HW722, HW723, HW724, HW725, HW726, HW727, HW728, HW729, HW730, HW731, HW732, HW733, HW735, HW736, HW737, HW738, HW740, HW742, HW743, HW744, HW745, HW746, HW747, HW750, HW751, HW752, HW753, HW754, HW755, HW756, HW757, HW758, HW759, HW760, HW761, HW762, HW763, HW765, HW766, HW767, HW769, HW771, HW772, HW773, HW774, HW775, HW776, HW777, HW778, HW779, HW780, HW781, HW782, HW783, HW784, HW791, HW792, HW793, HW794, HW800, HW802, HW804, HW805, HW806, HW807, HW808, HW809, HW810, HW811, HW813, HW828, HW829, HW830, HW831, HW832, HW833, HW834, HW836, HW837, HW838, HW839, HW840, HW841, HW842, HW843, HW844, HW845, HW846, HW847, HW848, HW849, HW851, HW852, HW853, HW854, HW855, HW856, HW862, HW868, HW869, HW870, HW871, HW872, HW873, HW874, HW875, HW876, HW878, HW880, HW881, HW882, HW883, HW884, HW892, HW893, HW894, HW895, HW896, HW897, HW898, HW899, HW900, HW902, HW903, HW904, HW905, HW906, HW907, HW908, HW909, HW910, HW912, HW913, HW914, HW915, HW916, HW918, HW924, HW925, HW927, HW929, HW934, HW937, HW938, HW940, HW941, HW942, HW944, HW945, HW946, HW948, HW949, HW950, HW951, HW952, HW953, HW954, HW955, HW956, HW981, HW982, HW983, HW984, HW985, HW986, HW987, HW988, HW989, HW990, HW991, HW992, HW993, HW994, HW995, HW996, HW997, HW998, HW999

Distribution

Worldwide

Quantity

892 units