# FDA recall Z-3251-2026

> **Abiomed, Inc.** · Class II · device recall initiated 2019-02-19.

## 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.     5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU.    6. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US.    7. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US.

## Reason for recall

Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure  signal the AIC system performance depends on.   2. Software defects leading to unreliable or missing placement signal, unresponsive start Impella soft key  during disconnect/reconnect, and false Position in Ventricle alarm in certain AICs.

## Distribution

Worldwide - US Nationwide and the countries of Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Luxembourg, Poland, Spain, Switzerland, United Kingdom.

## Key facts

- **Recall number:** Z-3251-2026
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-02-19
- **Report date:** 2026-09-30

- **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-3251-2026

## Citation

> MORVS. FDA recall Z-3251-2026. Retrieved 2026-10-26 from https://api.morvs.ai/recall/Z-3251-2026. Source: US FDA. Licensed CC0.

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