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Urgent site urgencyFDA Class I

Automated Impella Controller (AIC), for use with left heart support blood pump

Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.

Agency
FDA Device
Recall date
May 14, 2026
Status
Ongoing
Company
Abiomed, Inc.

1. What product was recalled?

Automated Impella Controller (AIC), for use with left heart support blood pump

Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 5. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 6. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 7. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 8. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 9. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 10. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 11. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 12.Impella Optical Controller, Packaged, US, UK; Product Code: 0042-0010-US. 13. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 14. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 15. Optical AIC w/Impella Connect, Pack'd, JP, EU; Product Code: 0042-0040-JP. 16. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU. 17. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 18. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US.

Quantity: 10,297 units

Code or lot text: All products below with software versions 6.0.1, 6.0.2, 6.0.3, 7.1 and above. 1. Product Code: 0042-0000-AU; GTIN: 00813502010886; Serial Numbers: IC5341, IC5523, IC5677, IC6531, IC5525, IC6529, IC5836, IC5524, IC7849, IC7850, IC7287, IC7288, IC7289, IC7290, IC6527, IC6526, IC6528, IC6530, IC5622, IC5752, IC5521, IC5522, IC5217, IC5216. 2. Product Code: 0042-0000-CA; GTIN: 00813502011272; Serial Numbers: IC9415, IC9413, IC9416, IC9414, IC8283, IC7716, IC7695, IC7694, IC6635, IC6636, IC6633, IC6634, IC6082, IC6083, IC5821, IC5824, IC5680, IC3802, IC2035, IC1912, IC5034, IC5050, IC4944, IC4945, IC3803, IC3661, IC3662, IC2686, IC2687, IC2033, IC1913, IC1790, IC1791, IC1911, IC1715, IC1769, IC1664, IC1595, IC1598, IC1543, IC1480, IC1481, IC1324, IC1346. 3. Product Code: 0042-0000-EU; GTIN: 00813502011289; Serial Numbers: IC7809, IC7720, IC7721, IC7748, IC7719, IC7718, IC7717, IC7691, IC7692, IC7693, IC7689, IC7690, IC7687, IC7688, IC7675, IC7686, IC7674, IC7667, IC7655, IC7666, IC7647, IC7648, IC7649, IC7650, IC7651, IC7652, IC7646, IC7653, IC7654, IC7613, IC7614, IC7615, IC7580, IC7578, IC7579, IC7576, IC7577, IC7421, IC7455, IC7407, IC7395, IC7406, IC7393, IC7394, IC7388, IC7389, IC7390, IC7392, IC7378, IC7286, IC7265, IC7263, IC7264, IC7261, IC7262, IC7258, IC7259, IC7260, IC7098, IC7099, IC7100, IC7078, IC7093, IC7087, IC7092, IC7096, IC7097, IC7094, IC7095, IC7077, IC7075, IC7076, IC6880, IC6876, IC6877, IC6878, IC6879, IC6845, IC6843, IC6813, IC6814, IC6810, IC6812, IC6804, IC6805, IC6806, IC6807, IC6808, IC6809, IC6716, IC6717, IC6728, IC6738, IC6739, IC6740, IC6741, IC6742, IC6713, IC6714, IC6710, IC6712, IC6711, IC6715, IC6708, IC6709, IC6594, IC6595, IC6688, IC6689, IC6690, IC6691, IC6692, IC6693, IC6694, IC6695, IC6706, IC6707, IC6591, IC6592, IC6593, IC6579, IC6577, IC6578, IC6587, IC6588, IC6589, IC6590, IC6582, IC6580, IC6581, IC6534, IC6535, IC6536, IC6487, IC6488, IC6449, IC6469, IC6441, IC6443, IC6440, IC6436, IC6437, IC6439, IC6432, IC6435, IC6434, IC6431, IC6331, IC6270, IC6064, IC6205, IC6275, IC6273, IC6274, IC6225, IC6236, IC6272, IC6223, IC6224, IC6149, IC6150, IC6151, IC6147, IC6081, IC6078, IC5818, IC5817, IC5781, IC5775, IC5777, IC5779, IC5755, IC5756, IC5754, IC5715, IC5716, IC5717, IC5685, IC5686, IC5611, IC5714, IC5722, IC5683, IC5684, IC5688, IC5560, IC5681, IC5682, IC5559, IC5518, IC5520, IC5517, IC5177, IC4839, IC4565, IC5519, IC5495, IC5496, IC5494, IC5490, IC5491, IC5492, IC5493, IC5487, IC5488, IC5476, IC5477, IC5460, IC5461, IC5463, IC5464, IC5462, IC5443, IC5441, IC5442, IC5440, IC5435, IC5436, IC5433, IC5434, IC5331, IC5356, IC5421, IC5422, IC5391, IC5392, IC5252, IC5195, IC5048, IC5193, IC5194, IC5178, IC5175, IC5176, IC5173, IC5174, IC5210, IC5212, IC5171, IC5169, IC5086, IC5051, IC5053, IC5075, IC5057, IC5087, IC5088, IC5046, IC5047, IC5049, IC5008, IC5009, IC4973, IC5007, IC4984, IC4986, IC4987, IC4988, IC4933, IC4934, IC4931, IC4932, IC4850, IC4928, IC4929, IC4930, IC4623, IC4470, IC4912, IC4917, IC4913, IC4915, IC4914, IC4916, IC4846, IC4837, IC4833, IC4834, IC4835, IC4836, IC4823, IC4824, IC4821, IC4822, IC4845, IC4840, IC4819, IC4820, IC4817, IC4818, IC4815, IC4816, IC4796, IC4797, IC4792, IC4793, IC4794, IC4795, IC4763, IC4790, IC4791, IC4781, IC4762, IC4760, IC4761, IC4758, IC4759, IC4748, IC4757, IC4737, IC4738, IC4735, IC4736, IC4733, IC4734, IC4723, IC4724, IC4728, IC4729, IC4725, IC4727, IC4679, IC4680, IC4677, IC4678, IC4657, IC4658, IC4648, IC4649, IC4646, IC4647, IC4645, IC4656, IC4634, IC4635, IC4636, IC4632, IC4633, IC4630, IC4631, IC4585, IC4629, IC4626, IC4624, IC4627, IC4613, IC4614, IC4611, IC4569, IC4566, IC4568, IC4610, IC4612, IC4609, IC4597, IC4598, IC4557, IC4567, IC4594, IC4595, IC4559, IC4564, IC4560, IC4561, IC4562, IC4563, IC4505, IC4506, IC4508, IC4501, IC4471, IC4500, IC4469, IC4466, IC4467, IC4464, IC4465, IC4468, IC4442, IC4443, IC4444, IC4445, IC4446, IC4370, IC4371, IC4367, IC4365, IC4366, IC4361, IC4359, IC4360, IC4358, IC4329, IC4328, IC4234, IC4362, IC4363, IC4356, IC4357, IC4323, IC4324, IC4325, IC4326, IC4322, IC4258, IC4252, IC4253, IC4251, IC4242, IC4241, IC4240, IC4254, IC4255, IC4256, IC4235, IC4238, IC4236, IC4230, IC4227, IC4228, IC4229, IC4210, IC4212, IC4207, IC4208, IC4218, IC4217, IC4209, IC4211, IC4175, IC4153, IC4151, IC4152, IC4150, IC4146, IC4147, IC4148, IC4149, IC4128, IC4129, IC4099, IC4100, IC4096, IC4097, IC4098, IC4083, IC4081, IC4036, IC4037, IC4034, IC4035, IC4033, IC4002, IC4006, IC4012, IC4013, IC4014, IC4015, IC3891, IC3889, IC3866, IC3867, IC3868, IC3869, IC3859, IC3861, IC3833, IC3834, IC3862, IC3863, IC3885, IC3886, IC3884, IC3870, IC3871, IC3872, IC3873, IC3874, IC3864, IC3860, IC3832, IC3830, IC3831, IC3828, IC3829, IC3815, IC3816, IC3777, IC3817, IC3818, IC3813, IC3814, IC3781, IC3782, IC3780, IC3812, IC3778, IC3724, IC3718, IC2710, IC3717, IC3706, IC3707, IC3708, IC3701, IC3703, IC3709, IC3698, IC3702, IC3699, IC3700, IC3697, IC3696, IC3673, IC3671, IC3672, IC3668, IC3670, IC3657, IC3669, IC3667, IC3495, IC3489, IC3492, IC3493, IC3486, IC3488, IC3487, IC3491, IC3659, IC3660, IC3490, IC3485, IC3484, IC3477, IC3472, IC3469, IC3470, IC3471, IC3467, IC3461, IC3462, IC3463, IC3466, IC3468, IC3458, IC3459, IC3331, IC3332, IC3460, IC3330, IC3329, IC3323, IC3313, IC3319, IC3327, IC3328, IC3324, IC3303, IC3321, IC3322, IC3317, IC3318, IC3315, IC3310, IC3314, IC3316, IC3311, IC3304, IC3305, IC3301, IC3302, IC3299, IC3300, IC3297, IC3298, IC3296, IC3291, IC3290, IC3289, IC3292, IC3286, IC3288, IC3287, IC3182, IC3183, IC3180, IC3181, IC3178, IC3179, IC3143, IC3144, IC3145, IC3146, IC3142, IC3147, IC3148, IC3149, IC3133, IC3134, IC3100, IC3101, IC3099, IC3102, IC3097, IC3098, IC3095, IC3096, IC3069, IC3070, IC3067, IC3068, IC3053, IC3054, IC3051, IC3052, IC3049, IC3021, IC3022, IC3018, IC3020, IC3019, IC3015, IC3016, IC3017, IC2996, IC2997, IC2987, IC2988, IC2984, IC2985, IC2960, IC2878, IC2961, IC2963, IC2962, IC2964, IC2873, IC2874, IC2875, IC2876, IC2877, IC2862, IC2860, IC2861, IC2858, IC2859, IC2855, IC2856, IC2829, IC2830, IC2835, IC2837, IC2836, IC2838, IC2828, IC2827, IC2766, IC2765, IC2823, IC2824, IC2825, IC2826, IC2763, IC2767, IC2757, IC2758, IC2712, IC2610, IC2751, IC2709, IC2752, IC2708, IC2678, IC2679, IC2676, IC2677, IC2670, IC2669, IC2668, IC2659, IC2658, IC2656, IC2657, IC2654, IC2655, IC2652, IC2653, IC2607, IC2609, IC2606, IC2560, IC2512, IC2556, IC2557, IC2491, IC2534, IC2490, IC2494, IC2483, IC2486, IC2481, IC2484, IC2485, IC2475, IC2441, IC2473, IC2474, IC2413, IC2414, IC2469, IC2470, IC2472, IC2412, IC2332, IC2411, IC2330, IC2329, IC2326, IC2327, IC2325, IC2242, IC2267, IC2268, IC2266, IC2241, IC2243, IC2234, IC2236, IC2232, IC2233, IC2204, IC2207, IC2222, IC2206, IC2220, IC2205, IC2099, IC2178, IC2179, IC2239, IC2240, IC2244, IC2235, IC2231, IC2173, IC2174, IC2171, IC2172, IC2101, IC2102, IC2095, IC2098, IC2097, IC2100, IC2096, IC2038, IC2039, IC2005, IC2006, IC1977, IC1978, IC1975, IC1976, IC1974, IC1886, IC1971, IC1972, IC1973, IC1908, IC1904, IC1907, IC1902, IC1903, IC1901, IC1881, IC1905, IC1775, IC1780, IC1872, IC1874, IC1870, IC1876, IC1825, IC1826, IC1821, IC1824, IC1764, IC1822, IC1823, IC1767, IC1768, IC1763, IC1766, IC1765, IC1727, IC1726, IC1761, IC1722, IC1723, IC1720, IC1685, IC1699, IC1700, IC1684, IC1677, IC1678, IC1676, IC1653, IC1594, IC1584, IC1590, IC1592, IC1490, IC1591, IC1585, IC1588, IC1578, IC1580, IC1579, IC1549, IC1547, IC1546, IC1548, IC1522, IC1523, IC1524, IC1525, IC1488, IC1413, IC1415, IC1411, IC1396, IC1397, IC1383, IC1350, IC1395, IC1384, IC1381, IC1393, IC1386, IC1344, IC1341, IC1343, IC1340, IC1345, IC1347, IC1349, IC1276, IC1288, IC1301, IC1302, IC1304, IC1305, IC1275, IC1265, IC1217. 4. Product Code: 0042-0000-IN; GTIN: 00813502011418; Serial Numbers: IC6475, IC6139, IC7410, IC7411, IC7408, IC7409, IC7079, IC7080, IC6477, IC6478, IC6476, IC6252, IC6253, IC6254. 5. Product Code: 0042-0000-JP; GTIN: 00813502010428; Serial Numbers: IC7901, IC8276, IC8277, IC8278, IC8279, IC8281, IC8082, IC8083, IC8084, IC8078, IC8079, IC8080, IC8081, IC8050, IC7929, IC7899, IC7900, IC7808, IC7811, IC8047, IC8048, IC8049, IC8051, IC8053, IC8054, IC8076, IC8077, IC7984, IC7853, IC7981, IC7982, IC7983, IC7985, IC8046, IC7934, IC7905, IC7926, IC7927, IC7933, IC7976, IC7979, IC7935, IC7977, IC7978, IC7980, IC7779, IC7902, IC7903, IC7897, IC7898, IC7852, IC7896, IC7812, IC7813, IC7814, IC7815, IC7846, IC7784, IC7785, IC7806, IC7782, IC7783, IC7749, IC7750, IC7751, IC7752, IC7753, IC7754, IC7755, IC7672, IC7673, IC7413, IC7593, IC7594, IC7606, IC7607, IC7608, IC7609, IC7610, IC7611, IC7612, IC7450, IC7451, IC7434, IC7435, IC7439, IC7440, IC7433, IC7412, IC7414, IC7415, IC7416, IC7417, IC7420, IC7422, IC7423, IC7424, IC7425, IC7426, IC7427, IC7429, IC7430, IC7431, IC7376, IC7377, IC7379, IC7380, IC7381, IC7382, IC7385, IC7386, IC7387, IC7383, IC7384, IC7291, IC7293, IC7294, IC7295, IC6985, IC7029, IC7031, IC7033, IC7034, IC7035, IC7102, IC7103, IC7104, IC7105, IC7256, IC7257, IC7081, IC7082, IC7083, IC7084, IC7085, IC7089, IC7090, IC7091, IC7068, IC7058, IC7059, IC7060, IC7061, IC7062, IC7063, IC7064, IC7065, IC7066, IC7067, IC6882, IC6883, IC6885, IC6886, IC6887, IC6888, IC6658, IC6659, IC6652, IC6653, IC6654, IC6855, IC6856, IC6857, IC6858, IC6859, IC6860, IC6861, IC6862, IC6863, IC6642, IC6745, IC6746, IC6747, IC6748, IC6749, IC6750, IC6751, IC6752, IC6662, IC6650, IC6651, IC6656, IC6657, IC6660, IC6661, IC6519, IC6605, IC6606, IC6607, IC6610, IC6548, IC6549, IC6550, IC6551, IC6552, IC6553, IC6554, IC6555, IC6556, IC6468, IC6533, IC6429, IC6430, IC6452, IC6490, IC6491, IC6492, IC6442, IC6451, IC6466, IC6467, IC6405, IC6406, IC6407, IC6388, IC6389, IC6306, IC6307, IC6308, IC6309, IC6310, IC6311, IC6312, IC6313, IC6314, IC6315, IC6316, IC6203, IC6204, IC6210, IC6211, IC6212, IC5866, IC5867, IC5868, IC6084, IC6085, IC6086, IC6087, IC6088, IC6089, IC6090, IC6049, IC6046, IC6047, IC6048, IC5935, IC5936, IC5937, IC5938, IC5862, IC5863, IC5930, IC5864, IC5865, IC5819, IC5820, IC5860, IC5861, IC5727, IC5728, IC5729, IC5731, IC5732, IC5733, IC5734, IC5735, IC5556, IC5563, IC5651, IC5652, IC5653, IC5654, IC5656, IC5657, IC5658, IC5659, IC5660, IC5665, IC5700, IC5505, IC5506, IC5507, IC5510, IC5511, IC5512, IC5515, IC5516, IC5478, IC5447, IC5444, IC5445, IC5259, IC5260, IC5261, IC5241, IC5243, IC5245, IC5027, IC4732. 6. Product Code: 0042-0000-UK; GTIN: 00813502011296; Serial Numbers: IC7668, IC7669, IC7670, IC7591, IC7073, IC7847, IC7848, IC7585, IC7443, IC7441, IC7074, IC7671, IC7070, IC7071, IC7444, IC7445, IC7446, IC7447, IC7069, IC7057, IC7056, IC6925, IC6585, IC6586, IC6583, IC6584, IC6542, IC6543, IC6537, IC6538, IC6638, IC6669, IC6670, IC6671, IC6291, IC6292, IC6286, IC6287, IC6289, IC6290, IC5914, IC5915, IC5926, IC5927, IC6001, IC5995, IC5996, IC5997, IC5998, IC5999, IC5910, IC5833, IC5831, IC5832, IC5554, IC5555, IC5553, IC5247, IC5830, IC5557, IC5213, IC5182, IC5180, IC5211, IC5254, IC5253, IC5219, IC5220, IC5218, IC5184, IC5214, IC5215, IC5179, IC5181, IC4857, IC4843, IC4844, IC4841, IC4842, IC4926, IC4927, IC4739, IC4741, IC4721, IC4722, IC4599, IC4600, IC4439, IC4440, IC4330, IC4166, IC3784, IC3785, IC3674, IC3474, IC3334, IC3333, IC3326, IC3325, IC3312, IC3295, IC3293, IC3294, IC2871, IC2872, IC2706, IC2707, IC2704, IC2705, IC2493, IC2497, IC2492, IC2496, IC2367, IC2023, IC1910, IC2024, IC2025, IC1909, IC1869, IC1868, IC1792, IC1581, IC1582, IC1583, IC1542, IC1519, IC1573, IC1387, IC1389, IC1388. 7. Product Code: 0042-0000-US; GTIN: 00813502010022; Serial Numbers: IC4744, IC7919, IC7922, IC7026, IC7028, IC7027, IC7030, IC7032, IC6983, IC6984, IC6982, IC6976, IC6977, IC6978, IC6979, IC6980, IC6981, IC6930, IC6931, IC6932, IC6933, IC6935, IC6926, IC6927, IC6928, IC6929, IC6918, IC6919, IC6920, IC6921, IC6922, IC6923, IC6898, IC6897, IC6916, IC6917, IC6889, IC6893, IC6894, IC6895, IC6901, IC6914, IC6915, IC6908, IC6909, IC6910, IC6911, IC6912, IC6913, IC6896, IC6899, IC6900, IC6904, IC6905, IC6906, IC6907, IC6841, IC6842, IC6840, IC6837, IC6838, IC6839, IC6836, IC6833, IC6829, IC6826, IC6827, IC6828, IC6831, IC6832, IC6811, IC6815, IC6865, IC6774, IC6864, IC6802, IC6803, IC6830, IC6801, IC6800, IC6798, IC6799, IC6823, IC6796, IC6797, IC6847, IC6848, IC6849, IC6824, IC6825, IC6846, IC6770, IC6771, IC6772, IC6773, IC6850, IC6851, IC6852, IC6853, IC6854, IC6769, IC6820, IC6822, IC6819, IC6775, IC6816, IC6817, IC6818, IC6767, IC6768, IC6732, IC6753, IC6754, IC6755, IC6766, IC6737, IC6743, IC6744, IC6733, IC6734, IC6735, IC6736, IC6515, IC4405, IC4404, IC6730, IC6731, IC6726, IC6727, IC6729, IC6725, IC6723, IC6724, IC6722, IC6718, IC6719, IC6720, IC6721, IC6678, IC6679, IC6680, IC6681, IC6682, IC6683, IC6684, IC6685, IC6686, IC6687, IC6675, IC6676, IC6677, IC6672, IC6674, IC6673, IC6668, IC6667, IC6663, IC6664, IC6665, IC6666, IC6647, IC6648, IC6649, IC6645, IC6646, IC6640, IC6641, IC6643, IC6644, IC6639, IC6637, IC6626, IC6627, IC6628, IC6629, IC6630, IC6631, IC6632, IC6624, IC6625, IC6620, IC6621, IC6622, IC6623, IC6619, IC6616, IC6617, IC6618, IC6613, IC6614, IC6615, IC6611, IC6612, IC6603, IC6604, IC6602, IC6601, IC6598, IC6599, IC6600, IC6596, IC6597, IC6575, IC6576, IC6573, IC6574, IC6569, IC6570, IC6571, IC6572, IC6568, IC6565, IC6566, IC6567, IC6563, IC6564, IC6562, IC6560, IC6561, IC6557, IC6558, IC6559, IC6544, IC6545, IC6546, IC6547, IC6524, IC6525, IC6522, IC6523, IC6518, IC6520, IC6521, IC6514, IC6516, IC6517, IC6511, IC6512, IC6513, IC6505, IC6506, IC6507, IC6508, IC6509, IC6504, IC6502, IC6503, IC6500, IC6499, IC6501, IC6497, IC6498, IC6448, IC6495, IC6496, IC6428, IC6445, IC6446, IC6447, IC6485, IC6486, IC6483, IC6484, IC6481, IC6482, IC6480, IC6433, IC6438, IC6479, IC6471, IC6472, IC6473, IC6470, IC6454, IC6455, IC6453, IC6426, IC6427, IC6444, IC6450, IC6415, IC6412, IC6413, IC6414, IC6411, IC6408, IC6409, IC6410, IC6404, IC6402, IC6403, IC6400, IC6401, IC6397, IC6398, IC6399, IC6045, IC6390, IC6391, IC6392, IC6393, IC6394, IC6395, IC6396, IC6361, IC6362, IC6363, IC6364, IC6365, IC6366, IC6367, IC6368, IC6369, IC6288, IC6295, IC6352, IC6353, IC6354, IC6355, IC6356, IC6357, IC6358, IC6359, IC6332, IC6333, IC6334, IC6335, IC6346, IC6347, IC6348, IC6349, IC6350, IC6351, IC6330, IC6328, IC6329, IC6326, IC6327, IC6325, IC6323, IC6324, IC6319, IC6320, IC6317, IC6318, IC1250, IC6095, IC6268, IC6269, IC6271, IC6255, IC6266, IC6267, IC6251, IC6250, IC6247, IC6248, IC6249, IC6244, IC6245, IC6246, IC6243, IC6242, IC6239, IC6240, IC6241, IC5933, IC6237, IC6238, IC6222, IC6220, IC6221, IC6218, IC6219, IC6217, IC6206, IC6208, IC6213, IC6215, IC6200, IC6201, IC6195, IC6196, IC6197, IC6198, IC6199, IC6194, IC6192, IC6193, IC6190, IC6191, IC6186, IC6187, IC6188, IC6189, IC6184, IC6185, IC6182, IC6183, IC6177, IC6178, IC6179, IC6180, IC6181, IC6176, IC6156, IC6157, IC6158, IC6159, IC6160, IC6161, IC6154, IC6155, IC6152, IC6153, IC6141, IC6144, IC6145, IC6146, IC6133, IC6134, IC6136, IC6142, IC6143, IC6140, IC6115, IC6135, IC6137, IC6138, IC5565, IC6129, IC6130, IC6131, IC6132, IC6128, IC6105, IC6106, IC6107, IC6103, IC6104, IC6100, IC6101, IC6102, IC6092, IC6093, IC6094, IC6096, IC6097, IC6098, IC6099, IC6077, IC6059, IC6063, IC6061, IC6062, IC6058, IC6060, IC6056, IC6057, IC6054, IC6055, IC6053, IC6051, IC6052, IC6050, IC6041, IC6043, IC6044, IC6042, IC6039, IC6040, IC6035, IC6036, IC6037, IC6038, IC6034, IC6000, IC6028, IC6029, IC6030, IC6031, IC6032, IC6033, IC6026, IC6027, IC6005, IC6002, IC6003, IC6004, IC5991, IC5992, IC5993, IC5994, IC5983, IC5985, IC5986, IC5987, IC5988, IC5989, IC5990, IC5984, IC5981, IC5982, IC5979, IC5980, IC5977, IC5978, IC5955, IC5976, IC5953, IC5954, IC5952, IC5950, IC5951, IC5946, IC5947, IC5948, IC5949, IC5945, IC5943, IC5944, IC5939, IC5940, IC5941, IC5942, IC5895, IC5906, IC5907, IC5908, IC5909, IC5891, IC5892, IC5893, IC5894, IC5890, IC5843, IC5889, IC5888, IC5881, IC5882, IC5883, IC5884, IC5885, IC5886, IC5887, IC5880, IC5794, IC5838, IC5776, IC5778, IC5879, IC5599, IC5872, IC5873, IC5874, IC5875, IC5876, IC5877, IC5878, IC5870,

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7.1 and above. 1. Product Code: 0042-0000-AU
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All products below with software versions 6.0.1
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GTIN: 00813502010022
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GTIN: 00813502010428
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IC1196
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IC1217. 4. Product Code: 0042-0000-IN
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IC4732. 6. Product Code: 0042-0000-UK
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IC5216. 2. Product Code: 0042-0000-CA
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Serial Numbers: IC4744
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Serial Numbers: IC9415
RECALL-NUMBER
Z-2360-2026

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is the hazard?

Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

Nationwide

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. The Recall Guy's urgency label is urgent, which is a separate deterministic site label.

9. When was the information checked?

Last checked .

  1. created

10. Where is the official source?

Open the official FDA Device source

The Recall Guy normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.