# FDA recall Z-2238-2026

> **Abiomed, Inc.** · Class I · device recall initiated 2011-01-17.

## Product

Automated Impella Controller (AIC) with the below product descriptions and 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.

## Reason for recall

Retrospective submission for following issues identified:   1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles.   2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Denmark, France, Germany, Italy, Kuwait, Netherlands, Norway, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.

## Key facts

- **Recall number:** Z-2238-2026
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2011-01-17
- **Report date:** 2026-06-03

- **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-2238-2026

## Citation

> MORVS. FDA recall Z-2238-2026. Retrieved 2026-10-16 from https://api.morvs.ai/recall/Z-2238-2026. Source: US FDA. Licensed CC0.

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