Z-3149-2026Class I

Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella...

Name: Z-3149-2026 Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella...
Creator: Abiomed, Inc.
Published: 2026-08-12
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2026-08-12 / Open, Classified

FDA source

Recall record

Recall number: Z-3149-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-08-12
Posted: 2026-09-16
Recalling firm: Abiomed, Inc.
Product: 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.
Product code: OZD Temporary Non-Roller Type Left Heart Support Blood Pump
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.
FDA root cause: Under Investigation by firm
Action: On August 12, 2026 URGENT MEDICAL DEVICE RECALL (REMOVAL) letters were sent to customers. Actions to be Taken: 1. Hospital inventory can continue to be used while awaiting service from Abiomed to ensure continuity of care. 2. Abiomed s field service team will contact you to schedule the specified replacement. 3. In the event of these purge flag component failures and associated alarms, as per IFU, first reinsert purge disc to address the alarm. If that action does not clear the alarm, switch to a backup Automated Impella Controller. 4. Ensure cleaning of the AIC housing with mild detergent as specified in the IFU. 5. Ensure future routine preventive maintenance is performed annually on your AIC(s) following the guidance in the IFU 6. Forward this notice to anyone in your facility that needs to be informed. 7. If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice. 8. Post a copy of this notice in a visible area for awareness.
Quantity in commerce: 1422 units (487 US, 935 OUS)
Distribution: 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;
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3149-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3148-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3149-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3150-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16

Product code OZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-18. View this recall on fda.gov (opens on fda.gov)