# FDA recall Z-2164-2025

> **Abiomed, Inc.** · Class I · device recall initiated 2025-06-23.

## 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; Product Code: 0042-0000-EU.    4. Impella Controller, Packaged, EU, Loaner; Product Code: 0042-0000-EU-L.    5. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN.    6. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP.    7. Impella Controller, Japan, Loaner; Product Code: 0042-0000-JP-L.     8. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK.     9. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L.     10. Impella Controller, Packaged, US; Product Code: 0042-0000-US.     11. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L.     12. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU.     13. Impella Optical Controller, Package

## Reason for recall

A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected

## Distribution

Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brunei Darussalam, Canada, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Pakistan, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.

## Key facts

- **Recall number:** Z-2164-2025
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-23
- **Report date:** 2025-08-06

- **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-2164-2025

## Citation

> AI Analytics. FDA recall Z-2164-2025. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-2164-2025. Source: US FDA. Licensed CC0.

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