Abiomed, Inc. recalls Automated Impella Controller

Recalling company

Abiomed, Inc.

Product

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.

Reason

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

Classification

Class I – a reasonable probability that use will cause serious adverse health consequences or death

Recall date

Aug 12, 2026

Reported

Sep 23, 2026

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;

Status

Ongoing

Quantity

5232 units (3733 US, 1499 OUS) 36 3

Lot / codes

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,

Company location

Danvers, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-3148-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-3148-2026 in the FDA Enforcement Report. Also see FDA recall press releases.