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.

Recall details

Manufacturer

Abiomed, Inc.

Distributor

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom.

Lot

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,

Risk classification

Class I

Area (FDA)

device

Country

United States