Summary
The FDA issued a Class II for HeartWare Model 1102 by Heartware, Inc.. 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 .
Details
Source
Device Recall
External ID
Z-0744-2023
Action Date
2022-12-28
Status
Ongoing
Category
device
Product Description
HeartWare Model 1102
Lot/Code Info: 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
Quantity Affected: 892 units
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.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-29
Company
Miami Lakes, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 404 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Heartware, Inc. has 39 FDA actions in our database, including 39 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Heartware, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Heartware, Inc. have FDA actions?
Heartware, Inc. has 39 FDA actions in our database, including 39 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0744-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
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