# FDA recall Z-0069-2026

> **Abiomed, Inc.** · Class I · device recall initiated 2025-10-01.

## Product

Automated Impella Controller (AIC), used for 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, EU, Loaner; Product Code: 0042-0000-EU-L.   5.	Impella Controller, Packaged, IN; Product Code: 0042-0000-IN.   6.	Impella Controller, Packaged, JP; Product Code: 0042-0000-JP.   7.	Impella Controller, Japan, Loaner; Product Code: 0042-0000-JP-L.   8.	Impella Controller, Packaged, UK; Product Code: 0042-0000-UK.   9.	Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L.   10.	Impella Controller, Packaged, US; Product Code: 0042-0000-US.   11.	Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L.   12.	Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU.   13.	Impella Optical Contro

## Reason for recall

Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).

## Distribution

Nationwide distribution. International distribution to United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Colombia, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom of Great Britain and Northern Ireland, Greece, Hong Kong, Croatia, 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-0069-2026
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-01
- **Report date:** 2025-10-15

- **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-0069-2026

## Citation

> AI Analytics. FDA recall Z-0069-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0069-2026. Source: US FDA. Licensed CC0.

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