FDA Device recall Z-3148-2026
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA
- FDA Device
- Class I
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class I recall of Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA by Abiomed, citing the potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3148-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-08-12 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Abiomed |
| Distribution | US |
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.
Identifiers
| code_info | 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA; UDI-DI: 00813502010022; Serial Numbers: IC1324, IC134…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, IC6 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3148-2026%22
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