Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90755

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 21, 2022
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Cardiac Assist, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1763-2022
Recall number
Z-1763-2022
Initiated
July 21, 2022
Classification
Class I
Status
Terminated
Recalling firm
Cardiac Assist, Inc
Quantity
723 units (484 currently in field)

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Failure of the LifeSPARC controller when the software

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

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

Distribution pattern

US Nationwide distribution.

Field note

Send feedback

We'll only use this to respond to your feedback.