- 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 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, IC67
- Units affected
- 1422 units (487 US, 935 OUS)
- 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-3149-2026
- 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