Abiomed, Inc.: 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 Controlle

Hazard

A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected

Details from the source

Reason for recall: A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected Distribution: 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 Quantity: 11,031 units Lot/code info: 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

UPC codes

813502010886, 813502011272, 813502011289, 813502011418, 813502010428, 813502011296, 813502010022

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.