Automated Impella Controller (AIC), used in left heart support blood pump, including the following:
Pending LLM rewrite. Source: FDA_DEVICE Z-2164-2025.
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
A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
The recalled product
- Product
- Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Pr
- 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)
- 1. Product Code: 0042-0000-AU
- GTIN Number: 813502010886
- Serial Numbers: IC7849
- IC7850
- IC7287
- IC7288
- IC7289
- IC7290
- IC6526
- IC6527
- IC6528
- IC6529
- IC6530
- IC6531
- IC5622
- IC5677
- IC5752
- IC5836
- IC5341
- IC5521
Distribution
Distributed nationwide across the United States.
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