# FDA recall Z-2360-2026

> **Abiomed, Inc.** · Class I · device recall initiated 2026-05-14.

## Product

Automated Impella Controller (AIC), for use with left heart support blood pump.  Labeled as the following with corresponding Product Codes:     1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU.     2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA.     3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU.    4. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN.     5. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP.     6. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK.     7. Impella Controller, Packaged, US; Product Code: 0042-0000-US.     8. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU.     9. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU.     10. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN.     11. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK.     12.Impella Optical Controller, Packaged, US, UK; Product Code: 0042-0010-US.     13. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA.     14. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU.     15. Optical AIC w/Impella Connect, Pack'd, JP, EU; Product Code: 0042-0040-JP.     16. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU.    17. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK.    18. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US.

## Reason for recall

Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom.

## Key facts

- **Recall number:** Z-2360-2026
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-14
- **Report date:** 2026-06-24

- **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-2360-2026

## Citation

> MORVS. FDA recall Z-2360-2026. Retrieved 2026-10-20 from https://api.morvs.ai/recall/Z-2360-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*