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.

Recall details

Manufacturer

Abiomed, Inc.

Distributor

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;

Lot

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, IC1

Risk classification

Class I

Area (FDA)

device

Country

United States