Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AI
Pending LLM rewrite. Source: FDA_DEVICE Z-0136-2026.
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 for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
The recalled product
- Product
- Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201. 3. Impella Controller, Packaged, AU, Product Code: 0042-00
- 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: 1000432
- GTIN: 00813502013030
- Serial Numbers pending correction as of 09/16/2025: IC11239
- IC11238
- IC10837
- IC10497
- IC10493
- IC10338
- IC10362. Serial Numbers corrected as of 09/16/2025: IC11404
- IC11401
- IC11400
- IC11399
- IC10827
- IC11237
- IC11236
- IC11232
- IC11231
- IC11230
- IC11227
- IC11210
Distribution
Distributed nationwide across the United States.
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