Z-3149-2026 Class I Ongoing
FDA device recall Z-3149-2026 was initiated by Abiomed, Inc. on August 12, 2026 and is designated Class I. 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. The recall status is ongoing. Affected quantity: 1422 units (487 US, 935 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2026
- Initiation Date
- August 12, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1422 units (487 US, 935 OUS)
Product Description
Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 3. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 4. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 5. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US.
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.
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;
Code Information
1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU; UDI-DI: 00813502010930; Serial Numbers: IC5130, IC5131; 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU; UDI-DI: 00813502010961; Serial Numbers: IC12955, IC12978, IC13013, IC13027, IC13042, IC13202, IC13223, IC13228, IC6947, IC6948, IC7625, IC7740, IC7741, IC8064, IC8065, IC8157, IC8158, IC8419, IC8727, IC7937, IC7940, IC9356, IC9363, IC9365, IC9369, IC9370, IC9371, IC9832, IC9833, IC5409, IC7794, IC7795, IC7796, IC7798, IC7799, IC7800, IC7945, IC7946, IC8069, IC8070, IC8263, IC8337, IC8341, IC8343, IC8441, IC8445, IC8447, IC8448, IC8449, IC8451, IC8861, IC9025, IC9028, IC9366, IC9799, IC8476A, IC9181A, IC13190, IC13205, IC9031, IC9094, IC9801, IC9865, IC9867, IC9973, IC7825, IC9095, IC8032, IC8126, IC8629, IC8630, IC8640, IC8641, IC9364, IC9368, IC9804, IC9805, IC9834, IC9835, IC8388, IC8751, IC9501, IC9972, IC10035, IC7629, IC7636, IC8164, IC8683, IC5592, IC6277, IC7046, IC7637, IC7638, IC7639, IC7640, IC7762, IC7763, IC7764, IC7765, IC8013, IC8057, IC8058, IC8128, IC8130, IC8131, IC8132, IC8387, IC8401, IC8402, IC8560, IC8621, IC8623, IC8748, IC8750, IC8752, IC8763, IC8814, IC9092, IC9432, IC11485, IC12328, IC12329, IC12332, IC12334, IC12346, IC13037, IC13038, IC8714, IC8775, IC8812, IC9005A, IC9006A, IC9008, IC9093, IC9096, IC9299, IC9783, IC9784, IC9961, IC7231, IC5037, IC5038, IC11162, IC11498, IC12326, IC12984, IC13239, IC13797, IC8488, IC8494, IC8503, IC8514, IC8588, IC8589, IC8642, IC8646, IC11691, IC4946, IC4947, IC4948, IC4949, IC4950, IC4951, IC4952, IC4953, IC4954, IC4955, IC4957, IC4958, IC4959, IC4960, IC4961, IC5039, IC5040, IC5041, IC5044, IC5045, IC5076, IC5077, IC5078, IC5079, IC5080, IC5081, IC5082, IC5084, IC5085, IC5096, IC5097, IC5098, IC5099, IC5100, IC5101, IC5102, IC5103, IC5104, IC5105, IC5106, IC5107, IC5108, IC5109, IC5110, IC5111, IC5112, IC5113, IC5114, IC5115, IC5126, IC5127, IC5128, IC5132, IC5133, IC5134, IC5135, IC5136, IC5137, IC5138, IC5139, IC5140, IC5141, IC5142, IC5143, IC5144, IC5145, IC5156, IC5157, IC5158, IC5159, IC5160, IC5161, IC5162, IC5163, IC5164, IC5233, IC5234, IC5235, IC5276, IC5277, IC5278, IC5279, IC5280, IC5281, IC5283, IC5284, IC5285, IC5350, IC5355, IC5376, IC5377, IC5378, IC5383, IC5396, IC5397, IC5399, IC5400, IC5401, IC5402, IC5403, IC5404, IC5407, IC5408, IC5410, IC5411, IC5412, IC5413, IC5414, IC5415, IC5526, IC5527, IC5528, IC5529, IC5530, IC5531, IC5532, IC5533, IC5534, IC5535, IC5566, IC5567, IC5568, IC5569, IC5570, IC5571, IC5572, IC5573, IC5574, IC5575, IC5576, IC5577, IC5578, IC5579, IC5581, IC5582, IC5583, IC5584, IC5585, IC5586, IC5587, IC5588, IC5589, IC5590, IC5591, IC5594, IC5595, IC5626, IC5627, IC5628, IC5629, IC5630, IC5631, IC5632, IC5633, IC5634, IC5635, IC5636, IC5638, IC5639, IC5640, IC5641, IC5642, IC5643, IC5644, IC5645, IC5666, IC5667, IC5668, IC5669, IC5671, IC5672, IC5801, IC5802, IC5803, IC5804, IC5805, IC5806, IC5807, IC5808, IC5809, IC5810, IC5811, IC5812, IC5813, IC5814, IC5896, IC5897, IC5898, IC5899, IC5900, IC5902, IC5903, IC5904, IC5905, IC5916, IC5918, IC5920, IC5921, IC5922, IC5923, IC5924, IC5925, IC5963, IC5964, IC5965, IC5966, IC5967, IC5968, IC6012, IC6013, IC6014, IC6015, IC6016, IC6017, IC6018, IC6019, IC6020, IC6021, IC6022, IC6023, IC6024, IC6025, IC6067, IC6068, IC6069, IC6070, IC6073, IC6074, IC6075, IC6116, IC6117, IC6120, IC6121, IC6122, IC6123, IC6124, IC6166, IC6167, IC6168, IC6169, IC6171, IC6172, IC6173, IC6174, IC6175, IC6226, IC6229, IC6230, IC6231, IC6232, IC6234, IC6235, IC6256, IC6257, IC6258, IC6259, IC6260, IC6265, IC6276, IC6278, IC6279, IC6280, IC6281, IC6282, IC6283, IC6297, IC6298, IC6299, IC6302, IC6303, IC6304, IC6305, IC6336, IC6337, IC6338, IC6339, IC6340, IC6341, IC6342, IC6343, IC6344, IC6345, IC6376, IC6377, IC6378, IC6379, IC6383, IC6384, IC6416, IC6417, IC6418, IC6421, IC6422, IC6460, IC6461, IC6462, IC6463, IC6465, IC6698, IC6703, IC6758, IC6776, IC6777, IC6779, IC6780, IC6781, IC6784, IC6785, IC6788, IC6789, IC6790, IC6791, IC6792, IC6793, IC6794, IC6795, IC6866, IC6867, IC6868, IC6869, IC6870, IC6871, IC6872, IC6873, IC6874, IC6875, IC6936, IC6937, IC6938, IC6939, IC6940, IC6941, IC6942, IC6943, IC6944, IC6945, IC6946, IC6949, IC6950, IC6951, IC6952, IC6954, IC6955, IC6986, IC6987, IC6988, IC7047, IC7048, IC7049, IC7050, IC7051, IC7052, IC7053, IC7054, IC7055, IC7156, IC7157, IC7158, IC7159, IC7160, IC7161, IC7163, IC7164, IC7226, IC7227, IC7232, IC7233, IC7234, IC7235, IC7266, IC7267, IC7268, IC7269, IC7270, IC7271, IC7272, IC7273, IC7274, IC7275, IC7356, IC7357, IC7358, IC7359, IC7360, IC7361, IC7362, IC7363, IC7364, IC7457, IC7458, IC7459, IC7460, IC7461, IC7462, IC7463, IC7464, IC7465, IC7523, IC7524, IC7525, IC7526, IC7528, IC7586, IC7587, IC7588, IC7589, IC7590, IC7620, IC7621, IC7622, IC7623, IC7624, IC7626, IC7627, IC7628, IC7710, IC7711, IC7738, IC7739, IC7792, IC7793, IC7821, IC7822, IC7823, IC7824, IC7826, IC7829, IC7830, IC7860, IC7863, IC7864, IC7865, IC7866, IC7867, IC7868, IC7869, IC7920, IC7939, IC7943, IC7944, IC7947, IC7953, IC7956, IC7958, IC7964, IC7965, IC8011, IC8012, IC8059, IC8060, IC8061, IC8063, IC8067, IC8068, IC8071, IC8073, IC8074, IC8075, IC8117, IC8118, IC8119, IC8122, IC8123, IC8124, IC8125, IC8145, IC8146, IC8159, IC8160, IC8161, IC8165, IC8201, IC8202, IC8203, IC8204, IC8205, IC8206, IC8217, IC8218, IC8219, IC8220, IC8221, IC8226, IC8252, IC8253, IC8254, IC8255, IC8256, IC8257, IC8258, IC8259, IC8260, IC8261, IC8262, IC8336, IC8340, IC8342, IC8344, IC8345, IC8395, IC8396, IC8397, IC8400, IC8403, IC8405, IC8421, IC8422, IC8423, IC8424, IC8439, IC8443, IC8444, IC8450, IC8457, IC8482, IC8486, IC8487, IC8499, IC8511, IC8512, IC8584, IC8586, IC8591, IC8592, IC8600, IC8610, IC8622, IC8625, IC8639, IC8643, IC8644, IC8645, IC8647, IC8648, IC8649, IC8661, IC8662, IC8663, IC8664, IC8690, IC8691, IC8693, IC8696, IC8723, IC8725, IC8726, IC8729, IC8737, IC8739, IC8931, IC8338, IC8339, IC8596, IC8608, IC8655, IC8665, IC8692, IC8761, IC8762, IC8813, IC9349, IC9372, IC7827, IC7828, IC8133, IC8134, IC9385, IC8404, IC8420, IC11746, IC12327, IC12344, IC13040, IC8425, IC8426, IC8427, IC8428, IC7861, IC7862, IC7954, IC7957, IC8120, IC8121, IC8222, IC8225, IC9027, IC9090, IC9091, IC8062, IC8066, IC5042, IC5129, IC5282, IC5580, IC5919, IC6118, IC6119, IC6261, IC6263, IC6459, IC7456, IC7529, IC7797, IC7941, IC7942, IC7955, IC8147, IC8442, IC8495, IC8513, IC8590, IC8753, IC8754, IC8755, IC8764, IC8765, IC9085, IC9230, IC9367, IC8875, IC9383, IC9796, IC9866, IC9974, IC10023, IC10024, IC9996, IC9998, IC11491, IC11451, IC11456, IC11497, IC11500, IC11741, IC11742, IC11745, IC11747, IC11748, IC11749; 3. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN; UDI-DI: 00813502011425; Serial Numbers: IC10063, IC10064, IC10149, IC10150, IC10238, IC10239, IC10341, IC10366, IC10367, IC12407, IC12408, IC12409, IC13057, IC13060, IC13061, IC13064, IC8609, IC8980, IC9177, IC9178, IC9324, IC9328, IC9557, IC9558, IC9744, IC9745, IC9746, IC9908, IC9921, IC9969, IC9970; 4. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK; UDI-DI: 00813502010978; Serial Numbers: IC8105, IC8106, IC8308, IC8315, IC8316, IC8335, IC8541, IC8542, IC8543, IC8895, IC9163, IC10013, IC10014, IC11023, IC11183, IC11442, IC12507, IC9133, IC9443, IC10012, IC10015, IC10039, IC10044, IC10319, IC10320, IC10640, IC10641, IC10645, IC10646, IC10648, IC10649, IC11019, IC11026, IC11027, IC11028, IC11048, IC11071, IC11086, IC11190, IC11201, IC11202, IC11441, IC11444, IC11445, IC11448, IC12503, IC12504, IC12579, IC12580, IC12581, IC12582, IC12719, IC12720, IC12721, IC12723, IC13159, IC13201, IC13204, IC13219, IC13220, IC13221, IC13278, IC13279, IC13280, IC8334, IC8767, IC8768, IC8774, IC9441, IC9445, IC9599, IC10040, IC10043, IC10808, IC11186, IC11211, IC11440, IC12505, IC12506, IC8101, IC8102, IC8103, IC8104, IC8544, IC9446, IC9449, IC8113, IC8114, IC8115, IC8116, IC8127, IC8129, IC8297, IC8331, IC8332, IC8333, IC8561, IC8563, IC8593, IC8594, IC9442, IC9444, IC9447, IC9448, IC9450, IC8295; 5. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US; UDI-DI: 00813502010985; Serial Numbers: IC11685, IC5970, IC5971, IC6956, IC6957, IC6958, IC6959, IC6960, IC6961, IC6962, IC6963, IC6964, IC6965, IC6966, IC6967, IC6968, IC6969, IC6970, IC6971, IC6972, IC6973, IC6974, IC6975, IC6996, IC6997, IC6998, IC6999, IC7000, IC7001, IC7002, IC7003, IC7004, IC7005, IC7006, IC7007, IC7009, IC7011, IC7012, IC7013, IC7014, IC7015, IC7016, IC7017, IC7018, IC7019, IC7020, IC7021, IC7022, IC7023, IC7024, IC7025, IC7036, IC7037, IC7038, IC7109, IC7110, IC7111, IC7112, IC7113, IC7114, IC7115, IC7116, IC7117, IC7118, IC7119, IC7120, IC7123, IC7125, IC7127, IC7128, IC7129, IC7130, IC7131, IC7132, IC7135, IC7136, IC7137, IC7138, IC7139, IC7150, IC7151, IC7152, IC7153, IC7154, IC7155, IC7166, IC7167, IC7168, IC7169, IC7170, IC7171, IC7172, IC7173, IC7174, IC7175, IC7176, IC7177, IC7178, IC7179, IC7192, IC7193, IC7194, IC7195, IC7196, IC7197, IC7198, IC7199, IC7200, IC7201, IC7202, IC7203, IC7204, IC7205, IC7206, IC7208, IC7209, IC7210, IC7211, IC7212, IC7213, IC7214, IC7215, IC7216, IC7217, IC7222, IC7223, IC7224, IC7225, IC7236, IC7237, IC7238, IC7239, IC7240, IC7241, IC7243, IC7244, IC7245, IC7246, IC7247, IC7249, IC7250, IC7251, IC7252, IC7253, IC7254, IC7255, IC7276, IC7277, IC7278, IC7279, IC7280, IC7281, IC7282, IC7283, IC7284, IC7285, IC7296, IC7297, IC7298, IC7299, IC7300, IC7301, IC7302, IC7303, IC7304, IC7305, IC7306, IC7307, IC7308, IC7313, IC7315, IC7316, IC7317, IC7318, IC7319, IC7320, IC7321, IC7322, IC7324, IC7325, IC7326, IC7327, IC7328, IC7329, IC7330, IC7331, IC7332, IC7333, IC7334, IC7335, IC7336, IC7337, IC7338, IC7344, IC7345, IC7346, IC7347, IC7348, IC7349, IC7350, IC7351, IC7352, IC7353, IC7354, IC7355, IC7366, IC7367, IC7368, IC7369, IC7370, IC7371, IC7372, IC7373, IC7374, IC7375, IC7396, IC7397, IC7398, IC7399, IC7400, IC7401, IC7402, IC7403, IC7404, IC7405, IC7466, IC7467, IC7468, IC7469, IC7470, IC7471, IC7472, IC7473, IC7474, IC7476, IC7477, IC7478, IC7479, IC7480, IC7481, IC7482, IC7483, IC7484, IC7485, IC7486, IC7487, IC7488, IC7489, IC7490, IC7491, IC7492, IC7493, IC7494, IC7495, IC7496, IC7497, IC7498, IC7499, IC7500, IC7501, IC7502, IC7503, IC7504, IC7505, IC7506, IC7507, IC7508, IC7509, IC7510, IC7511, IC7512, IC7513, IC7514, IC7515, IC7516, IC7517, IC7518, IC7534, IC7535, IC7536, IC7537, IC7538, IC7539, IC7540, IC7541, IC7542, IC7543, IC7544, IC7545, IC7547, IC7548, IC7549, IC7550, IC7551, IC7552, IC7553, IC7554, IC7555, IC7556, IC7557, IC7558, IC7559, IC7561, IC7564, IC7570, IC7573, IC7574, IC7599, IC7600, IC7601, IC7602, IC7603, IC7604, IC7605, IC7616, IC7617, IC7618, IC7619, IC7658, IC7659, IC7660, IC7661, IC7662, IC7663, IC7664, IC7665, IC7676, IC7677, IC7678, IC7679, IC7699, IC7700, IC7701, IC7702, IC7703, IC7704, IC7705, IC7706, IC7707, IC7712, IC7713, IC7714, IC7715, IC7726, IC7727, IC7728, IC7729, IC7730, IC7731, IC7732, IC7733, IC7734, IC7735, IC7736, IC7737, IC7742, IC7743, IC7744, IC7745, IC7756, IC7757, IC7758, IC7759, IC7760, IC7761, IC7771, IC7772, IC7773, IC7774, IC7775, IC7786, IC7787, IC7788, IC7789, IC7790, IC7791, IC7802, IC7803, IC7804, IC7805, IC7816, IC7817, IC7818, IC7819, IC7820, IC7877, IC7878, IC7879, IC7880, IC7882, IC7883, IC7884, IC7890, IC7893, IC7894, IC7906, IC7908, IC7974, IC8002, IC8003, IC8004, IC8006, IC8008, IC8026, IC8029, IC8034, IC8035, IC8037, IC8040, IC8041, IC10049, IC10066, IC10587, IC9228, IC9229, IC9610, IC9622, IC9773, IC9780, IC9781, IC9782, IC10102, IC10103, IC10318, IC10463, IC10589, IC10979, IC11299, IC12316, IC12758, IC12859, IC12900, IC13812, IC9989, IC10278, IC10302, IC10983, IC10984, IC10985, IC11174, IC11410, IC11656, IC11670, IC11674, IC11677, IC12214, IC12279, IC12414, IC12415, IC12417, IC12418, IC12419, IC12820, IC12857, IC12858, IC12870, IC12885, IC12973, IC12974, IC13231, IC13263, IC13264, IC13265, IC13268, IC13270, IC13271, IC13681, IC13682, IC9348, IC9500, IC9581, IC9648, IC9777, IC9793, IC9797, IC9915, IC9919, IC9922, IC7010, IC12884, IC12953, IC13232, IC13698, IC12968, IC13212, IC13269, IC13862;