HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.

What Should You Do?

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   Serial Numbers PC-10255-B, PC-10329-B, PC-10357-B, PC-10476-B, PC-10478-B, PC-10486-B, PC-10518-B, PC-10519-B, PC-10524-B, PC-10525-B, PC-10538-B, PC-10540-B, PC-10544-B, PC-10626-B, PC-10629-B, PC-10973-C, PC-10976-C, PC-10977-C, PC-10986-C, PC-10988-C, PC-11017-C, PC-11018-C, PC-11019-C, PC-11027-C, PC-11041-C, PC-11044-C, PC-11050-C, PC-11055-C, PC-11056-C, PC-11063-C, PC-11068-C, PC-11073-C, PC-11077-C, PC-11082-C, PC-11083-C, PC-11085-C, PC-11086-C, PC-11090-C, PC-11104-C, PC-11105-C, PC-11106-C, PC-11136-C, PC-11142-C, PC-11150-C, PC-11151-C, PC-11152-C, PC-11156-C, PC-11163-C, PC-11164-C, PC-11168-C, PC-11200-C, PC-11209-C, PC-11228-C, PC-11231-C, PC-11233-C, PC-11234-C, PC-11236-C, PC-11237-C, PC-11239-C, PC-11240-C, PC-11246-C, PC-11248-C, PC-11249-C, PC-11251-C, PC-11253-C, PC-11255, PC-11256-C, PC-11258, PC-11261-C, PC-11262-C, PC-11263-C, PC-11264-C, PC-11265-C, PC-11268-C, PC-11270-C, PC-11272-C, PC-11273-C, PC-11275-C, PC-11276-C, PC-11278-C, PC-11279-C, PC-11282-C, 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PC-23755-E, PC-23757-E, PC-23758-E, PC-23760-E, PC-23765-E, PC-23767-E, PC-23768-E, PC-23769-E, PC-23771-E, PC-23772-E, PC-23774-E, PC-23778-E, PC-23779-E, PC-23780-E, PC-23781-E, PC-23782-E, PC-23783-E, PC-23784-E, PC-23786-E, PC-23787-E, PC-23789-E, PC-23802-E, PC-23804-E, PC-23806-E, PC-23808-E, PC-23811-E, PC-23814-E, PC-23815-E, PC-23816-E, PC-23825-E, PC-23826-E, PC-23827-E, PC-23828-E, PC-23829-E, PC-23830-E, PC-23831-E, PC-23839-E, PC-23841-E, PC-24001, PC-24002, PC-24005, PC-24018, PC-24019, PC-24023, PC-24027, PC-24031, PC-24034, PC-24036, PC-24042, PC-24043, PC-24044, PC-24045, PC-24048, PC-24049, PC-24054, PC-24056, PC-24057, PC-24063, PC-24064, PC-24065, PC-24066, PC-24069, PC-24071, PC-24072, PC-24074, PC-24075, PC-24077, PC-24078, PC-24080, PC-24081, PC-24082, PC-24083, PC-24085, PC-24092, PC-24098, PC-24099, PC-24100, PC-24135, PC-24136, PC-24137, PC-24142, PC-24143, PC-24146, PC-24147, PC-24148, PC-24149, PC-24169, PC-24174, PC-24178, PC-24181, PC-24192, PC-24193, PC-24194, PC-24195, PC-24198, PC-24199, PC-24200, PC-24202, PC-24203, PC-24206, PC-24207, PC-24208, PC-24209, PC-24212, PC-24217, PC-24219, PC-24220, PC-24239, PC-24240, PC-24244, PC-24252, PC-24258, PC-24261, PC-24271, PC-24273, PC-24274, PC-24275, PC-24279, PC-24280, PC-24283, PC-24286, PC-24289, PC-24291, PC-24295, PC-24300, PC-24304, PC-24307, PC-24308, PC-24309, PC-24310, PC-24311, PC-24316, PC-24317, PC-24318, PC-24320, PC-24324, PC-24330, PC-24331, PC-24348-K, PC-24363-K, PC-24365-K, PC-24367, PC-24368, PC-24369, PC-24374, PC-24375, PC-24377, PC-24380, PC-24384, PC-24386, PC-24388, PC-24393, PC-24395, PC-24405, PC-24406, PC-24411, PC-24414, PC-24415, PC-24416, PC-24417, PC-24420, PC-24422, PC-24426, PC-24429, PC-24430, PC-24434, PC-24437, PC-24441, PC-24442, PC-24448, PC-24449, PC-24450, PC-24453, PC-24455, PC-24461, PC-24462, PC-24463, PC-24467, PC-24469, PC-24470, PC-24473, PC-24476, PC-24477, PC-24478, PC-24479, PC-24483, PC-24484, PC-24490, PC-24492, PC-24494, PC-24495, PC-24499, PC-24500, PC-24507, PC-24508, PC-24510, PC-24511, PC-24515, PC-24516, PC-24528, PC-24532, PC-24536, PC-24539, PC-24540, PC-24542, PC-24543, PC-24544, PC-24555, PC-24559, PC-24560, PC-24563, PC-24570, PC-24573, PC-24574, PC-24575, PC-24576, PC-24578, PC-24579, PC-24580, PC-24582, PC-24583, PC-24585, PC-24586, PC-24588, PC-24593, PC-24603, PC-24605, PC-24606, PC-24607, PC-24608, PC-24610, PC-24611, PC-24613, PC-24614, PC-24616, PC-24618, PC-24620, PC-24623-K, PC-24624-K, PC-24625-K, PC-24629-K, PC-24633, PC-24639, PC-24640, PC-24641, PC-24642-K, PC-24644-K, PC-24648, PC-24649, PC-24651, PC-24653, PC-24654, PC-24657, PC-24664, PC-24668, PC-24671, PC-24672, PC-24673, PC-24674, PC-24677, PC-24690-K, PC-24691-K, PC-24698, PC-24699, PC-24700, PC-24701, PC-24702-K, PC-24704-K, PC-24705-K, PC-24708, PC-24710, PC-24711, PC-24713, PC-24717, PC-24719, PC-24722, PC-24727, PC-24741, PC-24742, PC-24744, PC-24747, PC-24749, PC-24753, PC-24754, PC-24755, PC-24757, PC-24758, PC-24759, PC-24789, PC-24791, PC-24792, PC-24793, PC-24794, PC-24795, PC-24796, PC-24797, PC-24798, PC-24799, PC-24801, PC-24803, PC-24804, PC-24812, PC-24814, PC-24815, PC-24816, PC-24817, PC-24827, PC-24828, PC-24829, PC-24830, PC-24831, PC-24835, PC-24837, PC-24840, PC-24843, PC-24844, PC-24845, PC-24847, PC-24848, PC-24855, PC-24857, PC-24860, PC-24862, PC-24864, PC-24869, PC-24870, PC-24871, PC-24872, PC-24875, PC-24876, PC-24878, PC-24879, PC-24881, PC-24885, PC-24886, PC-24889, PC-24890, PC-24892, PC-24893, PC-24897, PC-24898, PC-24899, PC-24913, PC-24919, PC-24921, PC-24931, PC-24932, PC-24939, PC-24941, PC-24942, PC-24943, PC-24946, PC-24947, PC-24956, PC-24957, PC-24959, PC-24960, PC-24961, PC-24962, PC-24966, PC-24967, PC-24968, PC-24971, PC-24972, PC-24973, PC-24974, PC-24975, PC-24978, PC-24979, PC-24980, PC-24982, PC-24986, PC-24988, PC-24989, PC-24991, PC-24998, PC-24999, PC-25000, PC-25002, PC-25003, PC-25004, PC-25007, PC-25012, PC-25013, PC-25014, PC-25015, PC-25016, PC-25019, PC-25025, PC-25027, PC-25029, PC-25030, PC-25031, PC-25033, PC-25034, PC-25036, PC-25040, PC-25043, PC-25044, PC-25049, PC-25051, PC-25054, PC-25058, PC-25060, PC-25062, PC-25064, PC-25066, PC-25068, PC-25071, PC-25072, PC-25075, PC-25076, PC-25077, PC-25078, PC-25082, PC-25084, PC-25086, PC-25088, PC-25091, PC-25093, PC-25095, PC-25096, PC-25099, PC-25100, PC-25105, PC-25106, PC-25113, PC-25117, PC-25118, PC-25119, PC-25121, PC-25122, PC-25126, PC-25128, PC-25131, PC-25138, PC-25141, PC-25144, PC-25145, PC-25153, PC-25156, PC-25157, PC-25160, PC-25161, PC-25164, PC-25166, PC-25168, PC-25178, PC-25189, PC-25191, PC-25194, PC-25195, PC-25196, PC-25199, PC-25200, PC-25203, PC-25204, PC-25206, PC-25211, PC-25215-K, PC-25242-K, PC-25257
2. Do not eat it: Even if it looks and smells fine, do not consume this product.
3. Throw it away or return it: You can return the product to the store for a full refund.
4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
5. Report problems: Report any issues to the FDA's Safety Reporting Portal.