FDA Device recall Z-3149-2026
Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU
- FDA Device
- Class I
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class I recall of Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU 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-3149-2026 |
| 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
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.
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 Optical Controller, Packaged, AU; Product Code: 0042-0010-AU; UDI-DI: 00813502010930; Serial Numbers: IC513…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, IC763 |
|---|
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-3149-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.