Abiomed, Inc. medical device recall: Automated Impella Controller

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.

What the classification means

• Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Aug 12, 2026. FDA classified it 35 days later, on Sep 16, 2026. This recall event covers 3 separate products, each with its own FDA recall number. Distribution reported by FDA: 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… Abiomed, Inc. has 31 recalls in our records.

Recalled products (3)

• Z-3148-2026 Class I Ongoing

  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.

  Codes / lots: 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,…

  Quantity: 5232 units (3733 US, 1499 OUS) 36 3

• Z-3149-2026 Class I Ongoing

  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.

  Codes / 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,…

  Quantity: 1422 units (487 US, 935 OUS)

• Z-3150-2026 Class I Ongoing

  Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU. 2. Optical, AIC, Impella Connect, Packaged, CA; Product Code: 0042-0040-CA. 3. Optical, AIC, Impella Connect, Packaged, EU; Product Code: 0042-0040-EU. 4. Optical, AIC, Impella Connect, Packaged, JP; Product Code: 0042-0040-JP. 5. Optical, AIC, Impella Connect, Packaged, UK; Product Code: 0042-0040-UK. 6. Optical, AIC, Impella Connect, Packaged, US; Product Code: 0042-0040-US. 7. Optical, AIC, Impella Connect, Packaged, KR; Product Code: 0042-0040-KR;

  Codes / lots: 1. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU; UDI-DI: 00813502012972; Serial Numbers: IC12674, IC12675, IC13066, IC10162, IC10163, IC10387, IC10388, IC10747, IC10748, IC11472, IC11487, IC11489, IC11490, IC11544, IC11546, IC11566, IC12008, IC12054, IC12151, IC12583, IC12584, IC12804, IC13070, IC13071, IC13085, IC13093, IC13094, IC13095, IC13096, IC13233, IC13234, IC13561, IC13566, IC13749, IC13753; 2. Optical, AIC, Impella Connect, Packaged, CA; Product Code: 0042-0040-CA; UDI-DI: 00813502012958; Serial Numbers: IC10306, IC10312, IC11171, IC11172, IC12604, IC12605, IC12891, IC12892, IC12894, IC12895, IC13266, IC13267, IC13503, IC13504, IC13617, IC13618, IC13713, IC13714, IC13715, IC13716, IC13726, IC13801, IC13802; 3. Optical, AIC, Impella Connect, Packaged, EU; Product Code: 0042-0040-EU; UDI-DI: 00813502012217 Serial Numbers: IC10382, IC10419, IC10681,…

  Quantity: 4100 units (2785 US, 1315 OUS) 11 10