Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1
Pending LLM rewrite. Source: FDA_DEVICE Z-1591-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
The recalled product
- Product
- Automated Impella Controller (AIC), labeled as the following with 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, UK; Produc
- Manufacturer
- Abiomed, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN: 00813502011272
- Serial Numbers: IC2035
- IC9416. 2. Product Code: 0042-0000-EU
- GTIN: 00813502011289
- Serial Numbers: IC1677
- IC3049
- IC3099
- IC3102
- IC4358
- IC4329
- IC5774
- IC5757
- IC6580
- IC6581. 3. Product Code: 0042-0000-UK
- GTIN: 00813502011296
- Serial Numbers: IC2023
- IC1910
- IC2704
- IC3325
- IC3312. 4. Product Code: 0042-0000-US
Distribution
Distribution scope not specified by the agency.
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