HeartWare Model 1102
FDA Recall #Z-0744-2023 — Class II — November 29, 2022
Product Description
HeartWare Model 1102
Reason for Recall
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.
Recalling Firm
Heartware, Inc. — Miami Lakes, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
892 units
Distribution
Worldwide distribution.
Code Information
Serial Numbers: HW951, 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, HW952, HW953, HW954, HW955, HW956, HW981, HW982, HW983, HW984, HW985, HW986, HW987, HW988, HW989, HW990, HW991, HW992, HW993, HW994, HW995, HW996, HW997, HW998, HW999
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.