# FDA recall Z-2568-2025

> **Abiomed, Inc.** · Class I · device recall initiated 2025-08-20.

## Product

Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump.   1. Impella Controller, Packaged, US; Product Code: 0042-0000-US.  2. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L.   3. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA.   4. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU.  5. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK.   6. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L.

## Reason for recall

Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.

## Distribution

US distribution to AR, AZ, CA, CO, CT, FL, GA, ID, MA, MI, MO, MS, NJ, NY, OH, PA, TX.  International distribution to Canada, Germany, Great Britian, Italy, Netherlands, Norway.

## Key facts

- **Recall number:** Z-2568-2025
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-20
- **Report date:** 2025-10-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Danvers, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2568-2025

## Citation

> AI Analytics. FDA recall Z-2568-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2568-2025. Source: US FDA. Licensed CC0.

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