[pending] Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the foll
Pending LLM rewrite. Source: FDA_DEVICE Z-2360-2026.
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 software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
The recalled product
- Product
- Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA.
- 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)
- All products below with software versions 6.0.1
- 6.0.2
- 6.0.3
- 7.1 and above. 1. Product Code: 0042-0000-AU
- GTIN: 00813502010886
- Serial Numbers: IC5341
- IC5523
- IC5677
- IC6531
- IC5525
- IC6529
- IC5836
- IC5524
- IC7849
- IC7850
- IC7287
- IC7288
- IC7289
- IC7290
- IC6527
Distribution
Distributed nationwide across the United States.
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