# FDA recall Z-3148-2026

> **Abiomed, Inc.** · Class I · device recall initiated 2026-08-12.

## 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, IN; Product Code: 0042-0000-IN. 4. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 5. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 6. Impella Controller, Packaged, US; Product Code: 0042-0000-US.

## Reason for recall

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

## Distribution

Domestic: Nationwide Distribution.  International: United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Ireland, Israel, India, Italy, Japan, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan;

## Key facts

- **Recall number:** Z-3148-2026
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-08-12
- **Report date:** 2026-09-23

- **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-3148-2026

## Citation

> MORVS. FDA recall Z-3148-2026. Retrieved 2026-10-23 from https://api.morvs.ai/recall/Z-3148-2026. Source: US FDA. Licensed CC0.

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