Recall archive / FDA device enforcement

HeartWare Model 1102 — FDA record Z-0744-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 29, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: HeartWare Model 1102
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 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.
Classification: Class II
Recalling firm: Heartware, Inc.
Quantity: 892 units
Agency-reported status: Ongoing
Source record identifier: Z-0744-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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

Label field

Details supplied by the agency

Lot, code or applicability

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

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution.

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date: Dec 28, 2022
Recall initiation date: Nov 29, 2022
Center classification date: Dec 21, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records