# FDA recall Z-1591-2026

> **Abiomed, Inc.** · Class I · device recall initiated 2026-02-16.

## Product

Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes:     1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA.     2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU.     3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK.    4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.     5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU.     6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK.     7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA.     8. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU.     9. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU.

## Reason for recall

Potential that the "Purge System Blocked"  alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.

## Distribution

International distribution in the country of Australia, Canada, France, Germany, Kuwait.

## Key facts

- **Recall number:** Z-1591-2026
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-16
- **Report date:** 2026-04-08

- **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-1591-2026

## Citation

> AI Analytics. FDA recall Z-1591-2026. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1591-2026. Source: US FDA. Licensed CC0.

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