TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-000

Summary

The FDA issued a Class I for TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 59 by Cardiac Assist, Inc. Reason: Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data..

Details

Product Description

TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.

Lot/Code Info: Model 5900-0000 - UDI-DI: 00814112020562 Model 5900-0001 - UDI-DI: 00814112020623 Serial No.: C00115, C50232, C50253, C50403, C00195, C50619, C50623, C50161, C50167, C50388, C50432, C50505, C00189, C50437, C50671, C50690, C50362, C50648, C00048, C00087, C00149, C50274, C50506, C50308, C50319, C00040, C00107, C50160, C50016, C50604, C50493, C50355, C00126, C00155, C50113, C00041, C00135, C00042, C00035, C50012, C50019, C00176, C50386, C00052, C00076, C00092, C50490, C00095, C50149, C00182, C50392, C50337, C50451, C50306, C50460, C50512, C50082, C50092, C50174, C00151, C50328, C50349, C50111, C50501, C00157, C50363, C50353, C50476, C50212, C50219, C50350, C00174, C00006, C50076, C50105, C50235, C50613, C50197, C50375, C50463, C50517, C50632, C50662, C00199, C00205, C50699, C50269, C50398, C50618, C50645, C50100, C50101, C50626, C50204, C50266, C50330, C50031, C50050, C50241, C50524, C50181, C50365, C00038, C50237, C00190, C50598, C50005, C50213, C50214, C50283, C00143, C50287, C50288, C50259, C50285, C50270, C50639, C00158, C50357, C50601, C50289, C50059, C50065, C50043, C50037, C50072, C50096, C50153, C50140, C50703, C50391, C50536, C50682, C50314, C50354, C50470, C50409, C50526, C50146, C50225, C50226, C50001, C50090, C00169, C00023, C00161, C50224, C50230, C50254, C50458, C50525, C50581, C50591, C50378, C50428, C50466, C50539, C50303, C00063, C00071, C50211, C50229, C50280, C00167, C50374, C50387, C00141, C00136, C00145, C50312, C00073, C50243, C00150, C50222, C50343, C50425, C00053, C00057, C50652, C00113, C00114, C50038, C50247, C50651, C50521, C00072, C50485, C50492, C50057, C50126, C00152, C50530, C00086, C00094, C00181, C50389, C50399, C50453, C50169, C50148, C00148, C50456, C50015, C00098, C50465, C50448, C00179, C50406, C50026, C50044, C50162, C00016, C50056, C50170, C50042, C50058, C00039, C00078, C00093, C00089, C50157, C50234, C50236, C50318, C50395, C00166, C50327, C50356, C50410, C50471, C50262, C50385, C50195, C50196, C00132, C00130, C50381, C50436, C50435, C50047, C50055, C50064, C50429, C50370, C50377, C50486, C50627, C50664, C50066, C50078, C50468, C50093, C00129, C50186, C50338, C50483, C50216, C50077, C50108, C00180, C50414, C00079, C00172, C50248, C50257, C50592, C50640, C00083, C50041, C50364, C50452, C50074, C50479, C50575, C00201, C50046, C50326, C50498, C50430, C50438, C50607, C50018, C50175, C50014, C00144, C50477, C50418, C50267, C50119, C00128, C50024, C50185, C50256, C50290, C00165, C50400, C50508, C00015, C00044, C00045, C50344, C50631, C50649, C50635, C50182, C50198, C50251, C50503, C50084, C50122, C50130, C50115, C50228, C00184, C50507, C50087, C50532, C50188, C50104, C50531, C00051, C50051, C50123, C50294, C50444, C50600, C50271, C50272, C50296, C50313, C50279, C00138, C50194, C00054, C00081, C50376, C50624, C50630, C00171, C50434, C50457, C00175, C50599, C50263, C50497, C50496, C50494, C50322, C50411, C50107, C00146, C50089, C50473, C50176, C50307, C00194, C50171, C50459, C50616, C50636, C50647, C00085, C00137, C00139, C50298, C50348, C50215, C50351, C50667, C50663, C50641, C50120, C50109, C50537, C50145, C50514, C00109, C50035, C50010, C50080, C00046, C50393, C50397, C50446, C50462, C50644, C50657, C50656, C50439, C50449, C50334, C50052, C50062, C50190, C50300, C00163, C00164, C00043, C00082, C50033, C00156, C00080, C50070, C50003, C50004, C50020, C50191, C50187, C50405, C50422, C50511, C50116, C50184, C50143, C50154, C50060, C50063, C50299, C50379, C50488, C50331, C00183, C50136, C50139, C50177, C50141, C00178, C50582, C00088, C50025, C50193, C50495, C50007, C50110, C50164, C00168, C00050, C50221, C50489, C50596, C00206, C50685, C50584, C50673, C50324, C50345, C50382, C50320, C50472, C50474, C50183, C50205, C50323, C50440, C00192, C50629, C50579, C50646, C50661, C50589, C50321, C50424, C50192, C50220, C50252, C50402, C00066, C00101, C50481, C50029, C50217, C50233, C50467, C00049, C00062, C00200, C00204, C00068, C00034, C50255, C50342, C50309, C50361, C50006, C50048, C50036, C50068, C50401, C50333, C50081, C50049, C50103, C50346, C50347, C50519, C50152, C50297, C50369, C50373, C50189, C50292, C50316, C50528, C50620, C50246, C50242, C00056, C00077, C00160, C50595, C50594, C50311, C50304, C50121, C50454, C50239, C50273, C50282, C50416, C50621, C50504, C50441, C50587, C00154, C50227, C50368, C50478, C00170, C00173, C50339, C00153, C00159, C50264, C50396, C00055, C00105, C50284, C50605, C50132, C50583, C50231, C50240, C50461, C50352, C50383, C50527, C00112, C50028, C50013, C50159, C50455, C50295, C00074, C50201

Quantity Affected: 723 units (484 currently in field)

Reason for Recall

Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.

Type: Voluntary: Firm initiated

Recall Initiated: 2022-07-21

Company