Class 2 Device Recall Heartware

• Date Initiated by Firm: October 31, 2023
• Date Posted: December 02, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0476-2024
• Recall Event ID: 93405
• Product Classification: Ventricular (assist) bypass - Product Code DSQ
• Product: STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
• Code Information: Serial numbers: hw1005, HW1015, HW1020, HW1021, HW1022, HW1023, HW1025, HW1028, HW1031, HW1033, HW107, HW1088, HW1089, HW1090, HW1091, HW1092, HW1138, HW1139, HW1142, HW1143, HW1144, HW1146, HW1148, HW1171, HW1183, HW1200, HW1201, HW1202, HW1203, HW1204, HW1205, HW1209, HW1211, HW1222, HW1240, HW1241, HW1242, HW1243, HW1244, HW1245, HW1246, HW1247, HW1248, HW1249, HW1250, HW1252, HW1254, HW1257, HW1258, HW1261, HW1262, HW1263, HW1264, HW1265, HW1267, hw1273, HW1276, HW1277, HW1278, HW1280, HW1283, HW1292, HW1297, HW1305, HW1306, HW1308, HW1310, HW1311, HW134, HW1397, HW1398, HW1403, HW1404, HW1415, HW1426, HW1428, HW1430, HW1434, HW1437, HW1439, HW1441, HW1452, HW1454, HW1456, HW1457, HW1461, HW1462, HW1465, HW1466, HW1488, HW1510, HW1512, HW1517, HW1524, HW1528, HW1532, HW1533, HW1534, HW1535, HW1543, HW1553, HW1555, HW1556, HW1562, HW1573, HW1574, HW1589, HW1598, HW1608, HW1612, HW1618, HW1622, HW1627, HW1629, HW1630, HW1632, HW1633, HW1634, HW1636, HW1637, HW166, HW167, HW1688, HW1689, HW1694, HW1697, HW1728, HW1729, HW1733, HW174, HW1745, HW1748, HW1750, HW1757, HW176, HW1769, HW1771, HW1772, HW1801, HW1813, HW1816, HW1817, HW1818, HW182, HW184, HW187, HW190, HW191, HW1951, HW1955, HW196, HW1963, HW198, HW199, HW200, HW201, HW202, HW204, HW207, hw209, HW210, HW211, HW212, HW213, HW214, HW216, HW217, HW220, HW221, HW224, HW226, HW227, HW229, HW230, HW233, HW236, HW239, HW240, HW247, HW249, HW250, HW251, HW253, HW254, HW255, HW256, HW257, HW258, HW260, HW261, HW262, HW263, HW277, HW278, HW279, HW281, HW282, HW284, HW286, HW290, HW292, HW296, HW297, HW298, HW299, HW303, HW304, HW305, HW310, HW313, HW314, HW317, HW319, HW321, HW323, HW324, HW328, HW330, HW335, HW336, HW337, HW338, HW339, HW344, HW346, HW347, HW348, HW363, HW378, HW379, HW380, HW381, HW382, HW383, HW384, HW405, HW406, HW415, HW425, HW430, HW431, HW433, HW440, HW441, HW442, HW444, HW446, HW447, HW454, HW456, HW466, HW467, HW468, HW469, HW474, HW475, HW479, HW481, HW482, HW484, HW486, HW488, HW490, HW492, HW494, HW497, HW498, HW500, HW505, HW506, HW525, HW526, HW527, HW528, HW529, HW530, HW531, HW534, HW535, HW536, HW555, HW556, HW557, HW560, HW561, HW562, HW563, HW564, HW567, HW568, hw575, HW577, HW578, HW581, HW583, HW584, HW585, HW590, HW591, HW600, HW602, HW603, HW608, hw609, HW610, HW622, HW623, HW626, HW628, HW633, HW635, HW636, HW640, HW643, HW644, HW645, HW646, HW650, HW658, HW659, HW660, HW661, HW678, HW691, HW692, HW693, HW694, HW739, HW741, HW748, HW749, HW764, HW768, HW770, HW785, HW795, HW796, HW798, HW801, HW815, HW816, HW817, HW819, HW820, HW821, HW822, HW823, HW824, HW825, HW826, HW827, HW857, HW858, HW861, HW863, HW865, HW867, HW877, HW885, HW886, HW887, HW888, HW889, HW891, HW901, HW917, HW919, HW920, HW921, HW922, HW923, HW928, HW932, HW933, HW936, HW943, HW947, HW978, HW979, HW980
• Recalling Firm/ Manufacturer: Heartware, Inc.; 14400 Nw 60th Ave; Miami Lakes FL 33014-2807
• For Additional Information Contact: MCS Customer Service; 877-367-4823
• Manufacturer 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
• FDA Determined Cause: Labeling design
• Action: Heartware issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 10/31/2023 via letter (UPS). The notice explained the issue and informed them of the updates to the HVAD IFU and PM (patient manual).
• Quantity in Commerce: 380 units
• Distribution: Worldwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.