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.

Class I

Recalling firm: Abiomed, Inc.
Reason for recall: The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
Affected products (lot / model / serial): 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
Units affected: 5232 units (3733 US, 1499 OUS) 36 3
Distribution pattern: 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;
Firm location: Danvers, MA, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Letter
Product type: Devices
Status: Ongoing
Recall number: Z-3148-2026
Recall initiated: August 12, 2026
FDA classification date: September 16, 2026
FDA report date: September 23, 2026
FDA event ID: 99671
Last updated on HTM Vibe: September 29, 2026

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