Recall archive / FDA device enforcement

Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Co... — FDA record Z-3148-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Aug 12, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 4. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 5. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 6. Impella Controller, Packaged, US; Product Code: 0042-0000-US.
Reason: The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
Classification: Class I
Recalling firm: Abiomed, Inc.
Quantity: 5232 units (3733 US, 1499 OUS) 36 3
Agency-reported status: Ongoing
Source record identifier: Z-3148-2026

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What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA; UDI-DI: 00813502010022; Serial Numbers: IC1324, IC1346, IC1480, IC1481, IC1543, IC1544, IC1572, IC1595, IC1598, IC1664, IC1665, IC1715, IC1769, IC1790, IC1791, IC1911, IC1912, IC1913, IC2032, IC2033, IC2034, IC2035, IC2369, IC2370, IC2686, IC2687, IC3661, IC3662, IC3802, IC3803, IC4944, IC4945, IC5034, IC5050, IC5680, IC5821, IC5824, IC6082, IC6083, IC6633, IC6634, IC6635, IC6636, IC7694, IC7695, IC7716, IC8283, IC9413, IC9414, IC9415, IC9416; 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU; UDI-DI: 00813502011289; Serial Numbers: IC1347, IC1349, IC6845, IC1285, IC1416, IC2765, IC2766, IC3021, IC3022, IC3718, IC3719, IC3720, IC3776, IC5558, IC5559, IC1578, IC1585, IC1902, IC1903, IC1905, IC2678, IC2679, IC2855, IC2856, IC3053, IC3054, IC3329, IC3671, IC3672, IC3830, IC3831, IC4033, IC4837, IC5086, IC5169, IC5171, IC5560, IC5681, IC5682, IC5683, IC6064, IC6081, IC6149, IC6270, IC6272, IC6437, IC6439, IC6441, IC6443, IC6810, IC6812, IC6813, IC6814, IC7261, IC7262, IC7393, IC7394, IC7576, IC7577, IC7646, IC1825, IC1826, IC1870, IC1876, IC4153, IC4175, IC4657, IC4658, IC5476, IC5477, IC5518, IC5520, IC7263, IC7264, IC1011, IC1490, IC1584, IC1590, IC1592, IC2175, IC2176, IC2857, IC2996, IC2997, IC3291, IC3296, IC3317, IC3318, IC3486, IC3488, IC3698, IC3702, IC3724, IC3778, IC3864, IC3870, IC3890, IC3891, IC4151, IC4152, IC4323, IC4324, IC4471, IC4501, IC4681, IC4682, IC4851, IC4892, IC4933, IC4934, IC4973, IC4984, IC4986, IC4987, IC4988, IC5007, IC5048, IC5175, IC5176, IC5195, IC5421, IC5422, IC5433, IC5434, IC5441, IC5442, IC5460, IC5461, IC5463, IC5464, IC5494, IC5495, IC5496, IC5519, IC5611, IC5684, IC5687, IC5688, IC5714, IC5722, IC5818, IC6065, IC6534, IC6535, IC6536, IC6582, IC6587, IC6588, IC6589, IC6590, IC6688, IC6689, IC6690, IC6691, IC6692, IC6693, IC6694, IC6695, IC6706, IC6707, IC6728, IC6738, IC6739, IC6740, IC6741, IC6742, IC6876, IC6877, IC6878, IC6879, IC7388, IC7389, IC7390, IC7392, IC7647, IC7648, IC7649, IC7650, IC7651, IC7652, IC1284, IC2676, IC2677, IC2710, IC2827, IC2828, IC2989, IC3018, IC3020, IC3471, IC5775, IC5777, IC5779, IC5780, IC2099, IC2205, IC2220, IC2654, IC2655, IC2823, IC2824, IC2825, IC2826, IC3668, IC3670, IC3868, IC3869, IC4099, IC4100, IC4209, IC4218, IC4325, IC4326, IC4569, IC4611, IC4624, IC4627, IC4931, IC4932, IC5490, IC5491, IC5492, IC5493, IC6205, IC6275, IC6331, IC6432, IC6434, IC6435, IC6880, IC7407, IC7421, IC7455, IC7675, IC7686, IC7691, IC7692, IC7693, IC7717, IC7720, IC7721, IC7748, IC7809, IC3131, IC3132, IC1549, IC1580, IC2234, IC2236, IC2469, IC2652, IC2653, IC3069, IC3070, IC3311, IC3331, IC3332, IC3657, IC3669, IC3777, IC3828, IC3829, IC4150, IC1396, IC1397, IC1413, IC1415, IC1546, IC1548, IC1724, IC1725, IC1767, IC1768, IC2235, IC2239, IC2483, IC2486, IC2836, IC2838, IC3050, IC3673, IC3696, IC3697, IC4565, IC4839, IC5755, IC5756, IC6487, IC6488, IC7667, IC7674, IC7689, IC7690, IC3301, IC3302, IC1301, IC1302, IC1304, IC1305, IC1217, IC1276, IC1384, IC1386, IC1395, IC1522, IC1523, IC1547, IC1577, IC1579, IC1594, IC1676, IC1684, IC1699, IC1700, IC1722, IC1723, IC1764, IC1821, IC1824, IC1886, IC1974, IC2101, IC2102, IC2329, IC2862, IC2873, IC2874, IC2875, IC2876, IC2877, IC4002, IC4012, IC4013, IC4014, IC4015, IC4464, IC4465, IC4470, IC4566, IC4597, IC4598, IC4609, IC4623, IC4634, IC4635, IC4636, IC4645, IC4656, IC4833, IC4834, IC4835, IC4836, IC4850, IC4852, IC4928, IC4929, IC4930, IC5051, IC5053, IC5057, IC5075, IC5685, IC6579, IC6591, IC6592, IC6593, IC6594, IC6595, IC6708, IC6709, IC6711, IC6715, IC6716, IC6717, IC6804, IC6805, IC6806, IC6807, IC6808, IC6809, IC7098, IC7099, IC7100, IC7258, IC7259, IC7260, IC7580, IC7613, IC7614, IC7615, IC7687, IC7688, IC3817, IC3818, IC5008, IC5009, IC5046, IC5047, IC6223, IC6224, IC7286, IC7378, IC7087, IC7092, IC1265, IC1275, IC1280, IC1283, IC1288, IC1344, IC1345, IC1350, IC1383, IC1411, IC1653, IC1726, IC1761, IC1775, IC1780, IC1881, IC1901, IC1904, IC1907, IC1908, IC1971, IC1972, IC1973, IC1975, IC1976, IC1977, IC1978, IC2005, IC2006, IC2038, IC2039, IC2095, IC2096, IC2098, IC2171, IC2172, IC2173, IC2174, IC2204, IC2207, IC2231, IC2232, IC2233, IC2240, IC2241, IC2242, IC2243, IC2266, IC2267, IC2268, IC2325, IC2326, IC2327, IC2330, IC2332, IC2411, IC2412, IC2413, IC2414, IC2441, IC2473, IC2474, IC2475, IC2481, IC2484, IC2485, IC2490, IC2491, IC2494, IC2512, IC2534, IC2556, IC2557, IC2607, IC2609, IC2610, IC2658, IC2659, IC2670, IC2708, IC2712, IC2752, IC2757, IC2758, IC2763, IC2767, IC2829, IC2830, IC2858, IC2859, IC2878, IC2960, IC2962, IC2964, IC2984, IC2985, IC2987, IC2988, IC3017, IC3019, IC3051, IC3052, IC3067, IC3068, IC3095, IC3096, IC3099, IC3100, IC3101, IC3102, IC3133, IC3134, IC3142, IC3143, IC3144, IC3145, IC3146, IC3147, IC3148, IC3149, IC3178, IC3179, IC3180, IC3181, IC3286, IC3287, IC3288, IC3289, IC3290, IC3292, IC3297, IC3298, IC3299, IC3300, IC3303, IC3304, IC3305, IC3310, IC3313, IC3314, IC3315, IC3316, IC3319, IC3321, IC3322, IC3323, IC3324, IC3327, IC3328, IC3330, IC3458, IC3459, IC3460, IC3461, IC3462, IC3463, IC3466, IC3467, IC3468, IC3472, IC3477, IC3484, IC3485, IC3490, IC3492, IC3493, IC3495, IC3659, IC3660, IC3667, IC3701, IC3703, IC3706, IC3707, IC3708, IC3709, IC3717, IC3781, IC3782, IC3813, IC3814, IC3815, IC3816, IC3832, IC3833, IC3834, IC3859, IC3860, IC3861, IC3862, IC3863, IC3871, IC3872, IC3873, IC3884, IC3885, IC3886, IC3889, IC4034, IC4035, IC4036, IC4037, IC4083, IC4096, IC4097, IC4098, IC4128, IC4129, IC4146, IC4147, IC4148, IC4149, IC4207, IC4208, IC4210, IC4211, IC4212, IC4217, IC4227, IC4228, IC4229, IC4230, IC4234, IC4235, IC4236, IC4238, IC4240, IC4241, IC4242, IC4251, IC4252, IC4253, IC4258, IC4322, IC4328, IC4356, IC4357, IC4359, IC4360, IC4361, IC4362, IC4363, IC4365, IC4366, IC4367, IC4370, IC4371, IC4442, IC4443, IC4444, IC4445, IC4446, IC4466, IC4467, IC4468, IC4469, IC4500, IC4505, IC4506, IC4557, IC4559, IC4560, IC4561, IC4564, IC4567, IC4568, IC4585, IC4594, IC4595, IC4610, IC4612, IC4613, IC4614, IC4626, IC4629, IC4630, IC4631, IC4632, IC4633, IC4646, IC4647, IC4677, IC4678, IC4725, IC4727, IC4728, IC4729, IC4733, IC4734, IC4735, IC4736, IC4737, IC4738, IC4748, IC4757, IC4758, IC4759, IC4760, IC4761, IC4762, IC4763, IC4781, IC4792, IC4793, IC4794, IC4795, IC4796, IC4797, IC4815, IC4816, IC4817, IC4818, IC4819, IC4820, IC4821, IC4822, IC4823, IC4824, IC4840, IC4845, IC4848, IC4869, IC4875, IC5177, IC5517, IC1340, IC1488, IC1586, IC1588, IC1591, IC1677, IC2097, IC2100, IC2178, IC2179, IC2206, IC2244, IC2560, IC2606, IC2656, IC2668, IC2669, IC2709, IC2751, IC2837, IC3015, IC3048, IC3049, IC3097, IC3098, IC3182, IC3183, IC3487, IC3489, IC3491, IC3494, IC3780, IC3866, IC3867, IC4081, IC4329, IC4358, IC4562, IC4563, IC4648, IC4649, IC4723, IC4724, IC4790, IC4791, IC4912, IC4913, IC4915, IC4917, IC5174, IC5356, IC5443, IC5462, IC5686, IC5757, IC5774, IC6078, IC6079, IC6080, IC6147, IC6273, IC6274, IC6431, IC6580, IC6581, IC7077, IC7078, IC7718, IC7719, IC1872, IC1874, IC3704, IC3705, IC5049, IC5055, IC1341, IC1343, IC1381, IC1393, IC1685, IC1720, IC1727, IC1763, IC1765, IC1766, IC2470, IC2472, IC5178, IC5193, IC5194, IC5435, IC5436, IC5440, IC5715, IC5716, IC5717, IC5754, IC6225, IC6236, IC7653, IC7654, IC2442, IC2443, IC2444, IC2471, IC2476, IC2477, IC2478, IC2479, IC3127, IC3128, IC3129, IC3130, IC3306, IC3307, IC3308, IC3309, IC3656, IC3658, IC3663, IC3664, IC3665, IC3666, IC3783, IC3812, IC3887, IC3888, IC4068, IC4069, IC4254, IC4255, IC4256, IC4257, IC4507, IC4508, IC5087, IC5088, IC5210, IC5212, IC5251, IC5252, IC5357, IC5391, IC5392, IC5465, IC5466, IC5467, IC6164, IC6165, IC6214, IC6216, IC6293, IC6294, IC6370, IC6371, IC6372, IC6373, IC6374, IC6375, IC6386, IC6387, IC6510, IC7452, IC7453, IC7454, IC7581, IC7582, IC7583, IC7584, IC3469, IC3470, IC5487, IC5488, IC6449, IC6469, IC6577, IC6578, IC6710, IC6712, IC7093, IC7094, IC7095, IC7096, IC7097, IC7265, IC7395, IC7406, IC7578, IC7579, IC7655, IC7666, IC2961, IC2963, IC3699, IC3700, IC4679, IC4680, IC4914, IC4916, IC5781, IC5817, IC6150, IC6151, IC6436, IC6440, IC6713, IC6714, IC6843, IC7075, IC7076, IC7810, IC1398, IC1524, IC1587, IC1593, IC1678, IC1721, IC1822, IC2021, IC2040, IC2221, IC2222, IC2245, IC2331, IC2380, IC2657, IC2835, IC3016, IC3874, IC3875, IC4055, IC4231, IC4232, IC4233, IC4237, IC4502, IC4503, IC4628, IC4846, IC4911, IC5173, IC5331, IC5489, IC6076, IC6148, IC6474, IC6844; 3. 1. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN; UDI-DI: 00813502011418; Serial Numbers: IC6139, IC6252, IC6253, IC6254, IC6475, IC6476, IC6477, IC6478, IC7079, IC7080, IC7408, IC7409, IC7410, IC7411; 4. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP; UDI-DI: 00813502010428; Serial Numbers: IC4732, IC5027, IC5241, IC5243, IC5245, IC5259, IC5260, IC5261, IC5444, IC5445, IC5447, IC5478, IC5505, IC5506, IC5507, IC5510, IC5511, IC5512, IC5515, IC5516, IC5556, IC5563, IC5651, IC5652, IC5653, IC5654, IC5656, IC5657, IC5658, IC5659, IC5660, IC5665, IC5700, IC5727, IC5728, IC5729, IC5731, IC5732, IC5733, IC5734, IC5735, IC5819, IC5820, IC5860, IC5861, IC5862, IC5863, IC5864, IC5865, IC5866, IC5867, IC5868, IC5930, IC5935, IC5936, IC5937, IC5938, IC6046, IC6047, IC6048, IC6049, IC6084, IC6085, IC6086, IC6087, IC6088, IC6089, IC6090, IC6203, IC6204, IC6210, IC6211, IC6212, IC6306, IC6307, IC6308, IC6309, IC6310, IC6311, IC6312, IC6313, IC6314, IC6315, IC6316, IC6388, IC6389, IC6405, IC6406, IC6407, IC6429, IC6430, IC6442, IC6451, IC6452, IC6466, IC6467, IC6468, IC6490, IC6491, IC6492, IC6519, IC6533, IC6548, IC6549, IC6550, IC6551, IC6552, IC6553, IC6554, IC6555, IC6556, IC6605, IC6606, IC6607, IC6610, IC6642, IC6650, IC6651, IC6652, IC6653, IC6654, IC6656, IC6657, IC6658, IC6659, IC6660, IC6661, IC6662, IC6745, IC6746, IC6747, IC6748, IC6749, IC6750, IC6751, IC6752, IC6855, IC6856, IC6857, IC6858, IC6859, IC6860, IC6861, IC6862, IC6863, IC6882, IC6883, IC6885, IC6886, IC6887, IC6888, IC6985, IC7029, IC7031, IC7033, IC7034, IC7035, IC7058, IC7059, IC7060, IC7061, IC7062, IC7063, IC7064, IC7065, IC7066, IC7067, IC7068, IC7081, IC7082, IC7083, IC7084, IC7085, IC7089, IC7090, IC7091, IC7102, IC7103, IC7104, IC7105, IC7256, IC7257, IC7291, IC7293, IC7294, IC7295, IC7376, IC7377, IC7379, IC7380, IC7381, IC7382, IC7383, IC7384, IC7385, IC7386, IC7387, IC7412, IC7413, IC7414, IC7415, IC7416, IC7417, IC7420, IC7422, IC7423, IC7424, IC7425, IC7426, IC7427, IC7429, IC7430, IC7431, IC7433, IC7434, IC7435, IC7439, IC7440, IC7450, IC7451, IC7593, IC7594, IC7606, IC7607, IC7608, IC7609, IC7610, IC7611, IC7612, IC7672, IC7673, IC7749, IC7750, IC7751, IC7752, IC7753, IC7754, IC7755, IC7779, IC7782, IC7783, IC7784, IC7785, IC7806, IC7808, IC7811, IC7812, IC7813, IC7814, IC7815, IC7846, IC7852, IC7853, IC7896, IC7897, IC7898, IC7899, IC7900, IC7901, IC7902, IC7903, IC7905, IC7926, IC7927, IC7929, IC7933, IC7934, IC7935, IC7976, IC7977, IC7978, IC7979, IC7980, IC7981, IC7982, IC7983, IC7984, IC7985, IC8046, IC8047, IC8048, IC8049, IC8050, IC8051, IC8053, IC8054, IC8076, IC8077, IC8078, IC8079, IC8080, IC8081, IC8082, IC8083, IC8084, IC8276, IC8277, IC8278, IC8279, IC8281; 5. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK; UDI-DI: 00813502011296; Serial Numbers: IC1387, IC1389, IC1519, IC1542, IC1573, IC1792, IC1868, IC1869, IC1909, IC2277, IC2278, IC2493, IC2497, IC2871, IC2872, IC3293, IC3294, IC3295, IC3674, IC3675, IC3784, IC3785, IC4439, IC4440, IC4721, IC4722, IC4739, IC4741, IC4841, IC4842, IC5179, IC5181, IC5219, IC5220, IC5247, IC5553, IC5554, IC5555, IC5831, IC5832, IC5911, IC5912, IC5926, IC5927, IC6286, IC6287, IC6289, IC6290, IC6537, IC6538, IC6540, IC6583, IC6584, IC6585, IC6586, IC6925, IC7056, IC7057, IC7069, IC7070, IC7071, IC7073, IC7074, IC7441, IC7591, IC3326, IC3333, IC3334, IC3464, IC3465, IC3474, IC4599, IC4600, IC5914, IC5915, IC6542, IC6543, IC7776, IC7777, IC5254, IC5833, IC7444, IC7445, IC7446, IC7447, IC1388, IC1545, IC1581, IC1582, IC1583, IC2367, IC2368, IC249...

Label field

Details supplied by the agency

Lot, code or applicability

1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA; UDI-DI: 00813502010022; Serial Numbers: IC1324, IC1346, IC1480, IC1481, IC1543, IC1544, IC1572, IC1595, IC1598, IC1664, IC1665, IC1715, IC1769, IC1790, IC1791, IC1911, IC1912, IC1913, IC2032, IC2033, IC2034, IC2035, IC2369, IC2370, IC2686, IC2687, IC3661, IC3662, IC3802, IC3803, IC4944, IC4945, IC5034, IC5050, IC5680, IC5821, IC5824, IC6082, IC6083, IC6633, IC6634, IC6635, IC6636, IC7694, IC7695, IC7716, IC8283, IC9413, IC9414, IC9415, IC9416; 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU; UDI-DI: 00813502011289; Serial Numbers: IC1347, IC1349, IC6845, IC1285, IC1416, IC2765, IC2766, IC3021, IC3022, IC3718, IC3719, IC3720, IC3776, IC5558, IC5559, IC1578, IC1585, IC1902, IC1903, IC1905, IC2678, IC2679, IC2855, IC2856, IC3053, IC3054, IC3329, IC3671, IC3672, IC3830, IC3831, IC4033, IC4837, IC5086, IC5169, IC5171, IC5560, IC5681, IC5682, IC5683, IC6064, IC6081, IC6149, IC6270, IC6272, IC6437, IC6439, IC6441, IC6443, IC6810, IC6812, IC6813, IC6814, IC7261, IC7262, IC7393, IC7394, IC7576, IC7577, IC7646, IC1825, IC1826, IC1870, IC1876, IC4153, IC4175, IC4657, IC4658, IC5476, IC5477, IC5518, IC5520, IC7263, IC7264, IC1011, IC1490, IC1584, IC1590, IC1592, IC2175, IC2176, IC2857, IC2996, IC2997, IC3291, IC3296, IC3317, IC3318, IC3486, IC3488, IC3698, IC3702, IC3724, IC3778, IC3864, IC3870, IC3890, IC3891, IC4151, IC4152, IC4323, IC4324, IC4471, IC4501, IC4681, IC4682, IC4851, IC4892, IC4933, IC4934, IC4973, IC4984, IC4986, IC4987, IC4988, IC5007, IC5048, IC5175, IC5176, IC5195, IC5421, IC5422, IC5433, IC5434, IC5441, IC5442, IC5460, IC5461, IC5463, IC5464, IC5494, IC5495, IC5496, IC5519, IC5611, IC5684, IC5687, IC5688, IC5714, IC5722, IC5818, IC6065, IC6534, IC6535, IC6536, IC6582, IC6587, IC6588, IC6589, IC6590, IC6688, IC6689, IC6690, IC6691, IC6692, IC6693, IC6694, IC6695, IC6706, IC6707, IC6728, IC6738, IC6739, IC6740, IC6741, IC6742, IC6876, IC6877, IC6878, IC6879, IC7388, IC7389, IC7390, IC7392, IC7647, IC7648, IC7649, IC7650, IC7651, IC7652, IC1284, IC2676, IC2677, IC2710, IC2827, IC2828, IC2989, IC3018, IC3020, IC3471, IC5775, IC5777, IC5779, IC5780, IC2099, IC2205, IC2220, IC2654, IC2655, IC2823, IC2824, IC2825, IC2826, IC3668, IC3670, IC3868, IC3869, IC4099, IC4100, IC4209, IC4218, IC4325, IC4326, IC4569, IC4611, IC4624, IC4627, IC4931, IC4932, IC5490, IC5491, IC5492, IC5493, IC6205, IC6275, IC6331, IC6432, IC6434, IC6435, IC6880, IC7407, IC7421, IC7455, IC7675, IC7686, IC7691, IC7692, IC7693, IC7717, IC7720, IC7721, IC7748, IC7809, IC3131, IC3132, IC1549, IC1580, IC2234, IC2236, IC2469, IC2652, IC2653, IC3069, IC3070, IC3311, IC3331, IC3332, IC3657, IC3669, IC3777, IC3828, IC3829, IC4150, IC1396, IC1397, IC1413, IC1415, IC1546, IC1548, IC1724, IC1725, IC1767, IC1768, IC2235, IC2239, IC2483, IC2486, IC2836, IC2838, IC3050, IC3673, IC3696, IC3697, IC4565, IC4839, IC5755, IC5756, IC6487, IC6488, IC7667, IC7674, IC7689, IC7690, IC3301, IC3302, IC1301, IC1302, IC1304, IC1305, IC1217, IC1276, IC1384, IC1386, IC1395, IC1522, IC1523, IC1547, IC1577, IC1579, IC1594, IC1676, IC1684, IC1699, IC1700, IC1722, IC1723, IC1764, IC1821, IC1824, IC1886, IC1974, IC2101, IC2102, IC2329, IC2862, IC2873, IC2874, IC2875, IC2876, IC2877, IC4002, IC4012, IC4013, IC4014, IC4015, IC4464, IC4465, IC4470, IC4566, IC4597, IC4598, IC4609, IC4623, IC4634, IC4635, IC4636, IC4645, IC4656, IC4833, IC4834, IC4835, IC4836, IC4850, IC4852, IC4928, IC4929, IC4930, IC5051, IC5053, IC5057, IC5075, IC5685, IC6579, IC6591, IC6592, IC6593, IC6594, IC6595, IC6708, IC6709, IC6711, IC6715, IC6716, IC6717, IC6804, IC6805, IC6806, IC6807, IC6808, IC6809, IC7098, IC7099, IC7100, IC7258, IC7259, IC7260, IC7580, IC7613, IC7614, IC7615, IC7687, IC7688, IC3817, IC3818, IC5008, IC5009, IC5046, IC5047, IC6223, IC6224, IC7286, IC7378, IC7087, IC7092, IC1265, IC1275, IC1280, IC1283, IC1288, IC1344, IC1345, IC1350, IC1383, IC1411, IC1653, IC1726, IC1761, IC1775, IC1780, IC1881, IC1901, IC1904, IC1907, IC1908, IC1971, IC1972, IC1973, IC1975, IC1976, IC1977, IC1978, IC2005, IC2006, IC2038, IC2039, IC2095, IC2096, IC2098, IC2171, IC2172, IC2173, IC2174, IC2204, IC2207, IC2231, IC2232, IC2233, IC2240, IC2241, IC2242, IC2243, IC2266, IC2267, IC2268, IC2325, IC2326, IC2327, IC2330, IC2332, IC2411, IC2412, IC2413, IC2414, IC2441, IC2473, IC2474, IC2475, IC2481, IC2484, IC2485, IC2490, IC2491, IC2494, IC2512, IC2534, IC2556, IC2557, IC2607, IC2609, IC2610, IC2658, IC2659, IC2670, IC2708, IC2712, IC2752, IC2757, IC2758, IC2763, IC2767, IC2829, IC2830, IC2858, IC2859, IC2878, IC2960, IC2962, IC2964, IC2984, IC2985, IC2987, IC2988, IC3017, IC3019, IC3051, IC3052, IC3067, IC3068, IC3095, IC3096, IC3099, IC3100, IC3101, IC3102, IC3133, IC3134, IC3142, IC3143, IC3144, IC3145, IC3146, IC3147, IC3148, IC3149, IC3178, IC3179, IC3180, IC3181, IC3286, IC3287, IC3288, IC3289, IC3290, IC3292, IC3297, IC3298, IC3299, IC3300, IC3303, IC3304, IC3305, IC3310, IC3313, IC3314, IC3315, IC3316, IC3319, IC3321, IC3322, IC3323, IC3324, IC3327, IC3328, IC3330, IC3458, IC3459, IC3460, IC3461, IC3462, IC3463, IC3466, IC3467, IC3468, IC3472, IC3477, IC3484, IC3485, IC3490, IC3492, IC3493, IC3495, IC3659, IC3660, IC3667, IC3701, IC3703, IC3706, IC3707, IC3708, IC3709, IC3717, IC3781, IC3782, IC3813, IC3814, IC3815, IC3816, IC3832, IC3833, IC3834, IC3859, IC3860, IC3861, IC3862, IC3863, IC3871, IC3872, IC3873, IC3884, IC3885, IC3886, IC3889, IC4034, IC4035, IC4036, IC4037, IC4083, IC4096, IC4097, IC4098, IC4128, IC4129, IC4146, IC4147, IC4148, IC4149, IC4207, IC4208, IC4210, IC4211, IC4212, IC4217, IC4227, IC4228, IC4229, IC4230, IC4234, IC4235, IC4236, IC4238, IC4240, IC4241, IC4242, IC4251, IC4252, IC4253, IC4258, IC4322, IC4328, IC4356, IC4357, IC4359, IC4360, IC4361, IC4362, IC4363, IC4365, IC4366, IC4367, IC4370, IC4371, IC4442, IC4443, IC4444, IC4445, IC4446, IC4466, IC4467, IC4468, IC4469, IC4500, IC4505, IC4506, IC4557, IC4559, IC4560, IC4561, IC4564, IC4567, IC4568, IC4585, IC4594, IC4595, IC4610, IC4612, IC4613, IC4614, IC4626, IC4629, IC4630, IC4631, IC4632, IC4633, IC4646, IC4647, IC4677, IC4678, IC4725, IC4727, IC4728, IC4729, IC4733, IC4734, IC4735, IC4736, IC4737, IC4738, IC4748, IC4757, IC4758, IC4759, IC4760, IC4761, IC4762, IC4763, IC4781, IC4792, IC4793, IC4794, IC4795, IC4796, IC4797, IC4815, IC4816, IC4817, IC4818, IC4819, IC4820, IC4821, IC4822, IC4823, IC4824, IC4840, IC4845, IC4848, IC4869, IC4875, IC5177, IC5517, IC1340, IC1488, IC1586, IC1588, IC1591, IC1677, IC2097, IC2100, IC2178, IC2179, IC2206, IC2244, IC2560, IC2606, IC2656, IC2668, IC2669, IC2709, IC2751, IC2837, IC3015, IC3048, IC3049, IC3097, IC3098, IC3182, IC3183, IC3487, IC3489, IC3491, IC3494, IC3780, IC3866, IC3867, IC4081, IC4329, IC4358, IC4562, IC4563, IC4648, IC4649, IC4723, IC4724, IC4790, IC4791, IC4912, IC4913, IC4915, IC4917, IC5174, IC5356, IC5443, IC5462, IC5686, IC5757, IC5774, IC6078, IC6079, IC6080, IC6147, IC6273, IC6274, IC6431, IC6580, IC6581, IC7077, IC7078, IC7718, IC7719, IC1872, IC1874, IC3704, IC3705, IC5049, IC5055, IC1341, IC1343, IC1381, IC1393, IC1685, IC1720, IC1727, IC1763, IC1765, IC1766, IC2470, IC2472, IC5178, IC5193, IC5194, IC5435, IC5436, IC5440, IC5715, IC5716, IC5717, IC5754, IC6225, IC6236, IC7653, IC7654, IC2442, IC2443, IC2444, IC2471, IC2476, IC2477, IC2478, IC2479, IC3127, IC3128, IC3129, IC3130, IC3306, IC3307, IC3308, IC3309, IC3656, IC3658, IC3663, IC3664, IC3665, IC3666, IC3783, IC3812, IC3887, IC3888, IC4068, IC4069, IC4254, IC4255, IC4256, IC4257, IC4507, IC4508, IC5087, IC5088, IC5210, IC5212, IC5251, IC5252, IC5357, IC5391, IC5392, IC5465, IC5466, IC5467, IC6164, IC6165, IC6214, IC6216, IC6293, IC6294, IC6370, IC6371, IC6372, IC6373, IC6374, IC6375, IC6386, IC6387, IC6510, IC7452, IC7453, IC7454, IC7581, IC7582, IC7583, IC7584, IC3469, IC3470, IC5487, IC5488, IC6449, IC6469, IC6577, IC6578, IC6710, IC6712, IC7093, IC7094, IC7095, IC7096, IC7097, IC7265, IC7395, IC7406, IC7578, IC7579, IC7655, IC7666, IC2961, IC2963, IC3699, IC3700, IC4679, IC4680, IC4914, IC4916, IC5781, IC5817, IC6150, IC6151, IC6436, IC6440, IC6713, IC6714, IC6843, IC7075, IC7076, IC7810, IC1398, IC1524, IC1587, IC1593, IC1678, IC1721, IC1822, IC2021, IC2040, IC2221, IC2222, IC2245, IC2331, IC2380, IC2657, IC2835, IC3016, IC3874, IC3875, IC4055, IC4231, IC4232, IC4233, IC4237, IC4502, IC4503, IC4628, IC4846, IC4911, IC5173, IC5331, IC5489, IC6076, IC6148, IC6474, IC6844; 3. 1. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN; UDI-DI: 00813502011418; Serial Numbers: IC6139, IC6252, IC6253, IC6254, IC6475, IC6476, IC6477, IC6478, IC7079, IC7080, IC7408, IC7409, IC7410, IC7411; 4. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP; UDI-DI: 00813502010428; Serial Numbers: IC4732, IC5027, IC5241, IC5243, IC5245, IC5259, IC5260, IC5261, IC5444, IC5445, IC5447, IC5478, IC5505, IC5506, IC5507, IC5510, IC5511, IC5512, IC5515, IC5516, IC5556, IC5563, IC5651, IC5652, IC5653, IC5654, IC5656, IC5657, IC5658, IC5659, IC5660, IC5665, IC5700, IC5727, IC5728, IC5729, IC5731, IC5732, IC5733, IC5734, IC5735, IC5819, IC5820, IC5860, IC5861, IC5862, IC5863, IC5864, IC5865, IC5866, IC5867, IC5868, IC5930, IC5935, IC5936, IC5937, IC5938, IC6046, IC6047, IC6048, IC6049, IC6084, IC6085, IC6086, IC6087, IC6088, IC6089, IC6090, IC6203, IC6204, IC6210, IC6211, IC6212, IC6306, IC6307, IC6308, IC6309, IC6310, IC6311, IC6312, IC6313, IC6314, IC6315, IC6316, IC6388, IC6389, IC6405, IC6406, IC6407, IC6429, IC6430, IC6442, IC6451, IC6452, IC6466, IC6467, IC6468, IC6490, IC6491, IC6492, IC6519, IC6533, IC6548, IC6549, IC6550, IC6551, IC6552, IC6553, IC6554, IC6555, IC6556, IC6605, IC6606, IC6607, IC6610, IC6642, IC6650, IC6651, IC6652, IC6653, IC6654, IC6656, IC6657, IC6658, IC6659, IC6660, IC6661, IC6662, IC6745, IC6746, IC6747, IC6748, IC6749, IC6750, IC6751, IC6752, IC6855, IC6856, IC6857, IC6858, IC6859, IC6860, IC6861, IC6862, IC6863, IC6882, IC6883, IC6885, IC6886, IC6887, IC6888, IC6985, IC7029, IC7031, IC7033, IC7034, IC7035, IC7058, IC7059, IC7060, IC7061, IC7062, IC7063, IC7064, IC7065, IC7066, IC7067, IC7068, IC7081, IC7082, IC7083, IC7084, IC7085, IC7089, IC7090, IC7091, IC7102, IC7103, IC7104, IC7105, IC7256, IC7257, IC7291, IC7293, IC7294, IC7295, IC7376, IC7377, IC7379, IC7380, IC7381, IC7382, IC7383, IC7384, IC7385, IC7386, IC7387, IC7412, IC7413, IC7414, IC7415, IC7416, IC7417, IC7420, IC7422, IC7423, IC7424, IC7425, IC7426, IC7427, IC7429, IC7430, IC7431, IC7433, IC7434, IC7435, IC7439, IC7440, IC7450, IC7451, IC7593, IC7594, IC7606, IC7607, IC7608, IC7609, IC7610, IC7611, IC7612, IC7672, IC7673, IC7749, IC7750, IC7751, IC7752, IC7753, IC7754, IC7755, IC7779, IC7782, IC7783, IC7784, IC7785, IC7806, IC7808, IC7811, IC7812, IC7813, IC7814, IC7815, IC7846, IC7852, IC7853, IC7896, IC7897, IC7898, IC7899, IC7900, IC7901, IC7902, IC7903, IC7905, IC7926, IC7927, IC7929, IC7933, IC7934, IC7935, IC7976, IC7977, IC7978, IC7979, IC7980, IC7981, IC7982, IC7983, IC7984, IC7985, IC8046, IC8047, IC8048, IC8049, IC8050, IC8051, IC8053, IC8054, IC8076, IC8077, IC8078, IC8079, IC8080, IC8081, IC8082, IC8083, IC8084, IC8276, IC8277, IC8278, IC8279, IC8281; 5. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK; UDI-DI: 00813502011296; Serial Numbers: IC1387, IC1389, IC1519, IC1542, IC1573, IC1792, IC1868, IC1869, IC1909, IC2277, IC2278, IC2493, IC2497, IC2871, IC2872, IC3293, IC3294, IC3295, IC3674, IC3675, IC3784, IC3785, IC4439, IC4440, IC4721, IC4722, IC4739, IC4741, IC4841, IC4842, IC5179, IC5181, IC5219, IC5220, IC5247, IC5553, IC5554, IC5555, IC5831, IC5832, IC5911, IC5912, IC5926, IC5927, IC6286, IC6287, IC6289, IC6290, IC6537, IC6538, IC6540, IC6583, IC6584, IC6585, IC6586, IC6925, IC7056, IC7057, IC7069, IC7070, IC7071, IC7073, IC7074, IC7441, IC7591, IC3326, IC3333, IC3334, IC3464, IC3465, IC3474, IC4599, IC4600, IC5914, IC5915, IC6542, IC6543, IC7776, IC7777, IC5254, IC5833, IC7444, IC7445, IC7446, IC7447, IC1388, IC1545, IC1581, IC1582, IC1583, IC2367, IC2368, IC249...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Domestic: Nationwide Distribution. International: United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Ireland, Israel, India, Italy, Japan, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan;

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Sep 23, 2026
Recall initiation date: Aug 12, 2026
Center classification date: Sep 16, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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