Sterile Hvad recall
STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
Why was Sterile Hvad recalled?
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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
- Recalling firm
- Heartware, Inc.
- Quantity
- 380 units
- Distribution
- Worldwide
- Recall date
- December 13, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)