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U.S. Department of Health and Human Services

Class 1 Device Recall LIFESPARC Controller

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 Class 1 Device Recall LIFESPARC Controllersee related information
Date Initiated by FirmJuly 21, 2022
Date PostedSeptember 23, 2022
Recall Status1 Terminated 3 on August 08, 2023
Recall NumberZ-1763-2022
Recall Event ID 90755
510(K)NumberK183623 
Product Classification Control, pump speed, cardiopulmonary bypass - Product Code DWA
ProductTANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
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
Recalling Firm/
Manufacturer		 Cardiac Assist, Inc
240 Alpha Dr
Pittsburgh PA 15238-2906
For Additional Information ContactDeanna Wilke
281-228-7434 Ext. 227
Manufacturer Reason
for Recall		Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn July 21, 2022, the recalling firm notified impacted customers through mailed letters. Customers were instructed to use Operations Manual revision 15 and to discard all previous revisions of the Operations Manuals.
Quantity in Commerce723 units (484 currently in field)
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DWA
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