Z-1763-2022 Class I Terminated
FDA device recall Z-1763-2022 was initiated by Cardiac Assist, Inc on July 21, 2022 and is designated Class I. Reason for recall: Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data. The recall status is terminated (terminated August 8, 2023). Affected quantity: 723 units (484 currently in field).
Recall Details
- Product Type
- Devices
- Report Date
- October 5, 2022
- Initiation Date
- July 21, 2022
- Termination Date
- August 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 723 units (484 currently in field)
Product Description
TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
Reason for Recall
Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.
Distribution Pattern
US Nationwide distribution.
Code Information
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