# FDA recall Z-0136-2026

> **Abiomed, Inc.** · Class I · device recall initiated 2025-09-16.

## Product

Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes:  1. AIC w/Impella Connect for ECP, Product Code: 1000432.  2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201.  3. Impella Controller, Packaged, AU, Product Code: 0042-0000-AU.  4. Impella Controller, Packaged, CA, Product Code: 0042-0000-CA.  5. Impella Controller, Packaged, EU, Product Code: 0042-0000-EU.  6. Impella Controller, Packaged, IN, Product Code: 0042-0000-IN.  7. Impella Controller, Packaged, JP, Product Code: 0042-0000-JP.  8. Impella Controller, Packaged, UK, Product Code: 0042-0000-UK.  9. Impella Controller, Packaged, US, Product Code: 0042-0000-US.  10. Impella Optical Controller, Packaged, AU, Product Code: 0042-0010-AU.  11. Impella Optical Controller, Packaged, EU, Product Code: 0042-0010-EU.  12. Impella Optical Controller, Packaged, IN, Product Code: 0042-0010-IN.  13. Impella Optical Controller, Packaged, UK, Product Code: 0042-0010-UK.  14. Impella Opti

## Reason for recall

Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.

## Distribution

Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brazil, Canada, Columbia, Croatia, Czechia, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Isreal, Italy, Japan, Kuwait, Luxembourg, Mexico, Netherlands, Pakistan, Panama, Poland, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland.

## Key facts

- **Recall number:** Z-0136-2026
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-16
- **Report date:** 2025-10-29

- **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-0136-2026

## Citation

> AI Analytics. FDA recall Z-0136-2026. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0136-2026. Source: US FDA. Licensed CC0.

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