Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 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, EU, Loaner; Product Code: 0042-0000-EU-L. 5. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 6. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 7. Impella Controller, Japan, Loaner; Product Code: 0042-0000-JP-L. 8. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 9. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L. 10. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 11. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 12. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 13. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 14. Impella Optical Controller, EU, Loaner; Product Code: 0042-0010-EU-L. 15. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 16. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 17. Impella Optical Controller, UK, Loaner; Product Code: 0042-0010-UK-L. 18. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US. 19. Impella Optical Controller, US, Loaner; Product Code: 0042-0010-US-L. 20. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU. 21. Optical AIC w/Impella Connect, Packaged, CA; Product Code: 0042-0040-CA. 22. AIC w/Remote Link, Packaged, Cln Trl, US; Product Code: 0042-0040-CT-L. 23. Optical AIC w/Impella Connect, Packaged, EU; Product Code: 0042-0040-EU. 24. Optical AIC w/Impella Connect, EU, Loaner; Product Code: 0042-0040-EU-L. 25. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP. 26. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP-L. 27. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 28. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US. 29. Optical AIC Impella Connect, US, Loaner; Product Code: 0042-0040-US-L. 30. Dbl optical, AIC Impella Connect, Phg US; Product Code: 1000201. 31. AIC w/Impella Connect for ECP; Product Code: 1000432.

Recall details

Manufacturer

Abiomed, Inc.

Distributor

Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brunei Darussalam, Canada, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Pakistan, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.

Lot

1. Product Code: 0042-0000-AU; GTIN Number: 813502010886; Serial Numbers: IC7849, IC7850, IC7287, IC7288, IC7289, IC7290, IC6526, IC6527, IC6528, IC6529, IC6530, IC6531, IC5622, IC5677, IC5752, IC5836, IC5341, IC5521, IC5522, IC5523, IC5524, IC5525, IC5237, IC5216, IC5217, IC5236, IC5238. 2. Product Code: 0042-0000-CA; GTIN Number: 813502011272; Serial Numbers: IC9416, IC9414, IC9415, IC9413, IC8283, IC7695, IC7716, IC7694, IC6633, IC6634, IC6635, IC6636, IC6082, IC6083, IC5821, IC5824, IC5680, IC5034, IC5050, IC4944, IC4945, IC3802, IC3803, IC3661, IC3662, IC2686, IC2687, IC2369, IC2370, IC2033, IC2035, IC2032, IC2034, IC1911, IC1912, IC1913, IC1790, IC1791, IC1715, IC1769, IC1664, IC1665, IC1595, IC1598, IC1572, IC1543, IC1544, IC1480, IC1481, IC1324, IC1346. 3. Product Code: 0042-0000-EU; GTIN Number: 813502011289; Serial Numbers: IC7809, IC7717, IC7718, IC7719, IC7720, IC7721, IC7748, IC7674, IC7675, IC7686, IC7687, IC7688, IC7689, IC7690, IC7691, IC7692, IC7693, IC7653, IC7654, IC7655, IC7666, IC7667, IC7646, IC7647, IC7648, IC7649, IC7650, IC7651, IC7652, IC7613, IC7614, IC7615, IC7421, IC7576, IC7577, IC7578, IC7579, IC7580, IC7581, IC7582, IC7583, IC7584, IC7455, IC7452, IC7453, IC7454, IC7378, IC7388, IC7389, IC7390, IC7392, IC7393, IC7394, IC7407, IC7395, IC7406, IC7263, IC7264, IC7265, IC7286, IC7258, IC7259, IC7260, IC7261, IC7262, IC7087, IC7092, IC7093, IC7094, IC7095, IC7096, IC7097, IC7098, IC7099, IC7100, IC7075, IC7076, IC7077, IC7078, IC6843, IC6844, IC6845, IC6876, IC6877, IC6878, IC6879, IC6880, IC6804, IC6805, IC6806, IC6807, IC6808, IC6809, IC6810, IC6812, IC6813, IC6814, IC6728, IC6738, IC6739, IC6740, IC6741, IC6742, IC6710, IC6711, IC6712, IC6713, IC6714, IC6715, IC6716, IC6717, IC6688, IC6689, IC6690, IC6691, IC6692, IC6693, IC6694, IC6695, IC6706, IC6707, IC6708, IC6709, IC6587, IC6588, IC6589, IC6590, IC6591, IC6592, IC6593, IC6594, IC6595, IC6577, IC6578, IC6579, IC6582, IC6580, IC6581, IC6534, IC6535, IC6536, IC6510, IC6449, IC6469, IC6474, IC6487, IC6488, IC6489, IC6437, IC6439, IC6440, IC6441, IC6443, IC6431, IC6432, IC6435, IC6436, IC6434, IC6370, IC6371, IC6372, IC6373, IC6374, IC6375, IC6386, IC6387, IC6270, IC6331, IC6205, IC6214, IC6216, IC6293, IC6294, IC6272, IC6273, IC6274, IC6275, IC6223, IC6224, IC6225, IC6236, IC6164, IC6165, IC6147, IC6148, IC6149, IC6150, IC6151, IC6078, IC6081, IC6079, IC6080, IC6064, IC6076, IC5817, IC5818, IC5774, IC5775, IC5777, IC5779, IC5781, IC5780, IC5754, IC5755, IC5756, IC5757, IC5611, IC5714, IC5715, IC5716, IC5717, IC5722, IC5681, IC5682, IC5683, IC5684, IC5685, IC5686, IC5688, IC5687, IC5559, IC5560, IC5558, IC5517, IC5518, IC5519, IC5520, IC5495, IC5496, IC5487, IC5488, IC5489, IC5490, IC5491, IC5492, IC5493, IC5494, IC5476, IC5477, IC5357, IC5465, IC5466, IC5467, IC5460, IC5461, IC5462, IC5463, IC5464, IC5440, IC5441, IC5442, IC5443, IC5433, IC5434, IC5435, IC5436, IC5331, IC5356, IC5421, IC5422, IC5391, IC5392, IC5251, IC5252, IC5193, IC5194, IC5195, IC5210, IC5212, IC5169, IC5171, IC5173, IC5174, IC5175, IC5176, IC5177, IC5178, IC5051, IC5053, IC5075, IC5086, IC5087, IC5088, IC5046, IC5047, IC5048, IC5049, IC5057, IC5055, IC4973, IC5007, IC5008, IC5009, IC4984, IC4986, IC4987, IC4988, IC4850, IC4928, IC4929, IC4930, IC4931, IC4932, IC4933, IC4934, IC4911, IC4912, IC4913, IC4914, IC4915, IC4916, IC4917, IC4845, IC4846, IC4833, IC4834, IC4835, IC4836, IC4837, IC4839, IC4840, IC4823, IC4824, IC4815, IC4816, IC4817, IC4818, IC4819, IC4820, IC4821, IC4822, IC4790, IC4791, IC4792, IC4793, IC4794, IC4795, IC4796, IC4797, IC4781, IC4748, IC4757, IC4758, IC4759, IC4760, IC4761, IC4762, IC4763, IC4723, IC4724, IC4733, IC4734, IC4735, IC4736, IC4737, IC4738, IC4725, IC4727, IC4728, IC4729, IC4677, IC4678, IC4679, IC4680, IC4681, IC4682, IC4645, IC4646, IC4647, IC4648, IC4649, IC4656, IC4657, IC4658, IC4585, IC4630, IC4631, IC4632, IC4633, IC4634, IC4635, IC4636, IC4623, IC4624, IC4626, IC4627, IC4628, IC4629, IC4609, IC4610, IC4611, IC4612, IC4613, IC4614,

Risk classification

Class I

Area (FDA)

device

Country

United States