[pending] Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AI
Pending LLM rewrite. Source: FDA_DEVICE Z-0136-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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