The Recall Desk
Severity pendingFDA (Devices)·Z-0069-2026·Announced 2025-10-15

Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following

Pending LLM rewrite. Source: FDA_DEVICE Z-0069-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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

The recalled product

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
Manufacturer
Abiomed, Inc.
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1. Product Code: 0042-0000-AU
  • GTIN: 813502010886
  • All Serial Numbers. 2. Product Code: 0042-0000-CA
  • GTIN: 813502011272
  • All Serial Numbers. 3. Product Code: 0042-0000-EU
  • GTIN: 813502011289
  • All Serial Numbers. 4. Product Code: 0042-0000-EU-L
  • All Serial Numbers. 5. Product Code: 0042-0000-IN
  • GTIN: 813502011418
  • All Serial Numbers. 6. Product Code: 0042-0000-JP
  • GTIN: 813502010428
  • All Serial Numbers. 7. Product Code: 0042-0000-JP-L
  • All Serial Numbers. 8. Product Code: 0042-0000-UK
  • GTIN: 813502011296
  • All Serial Numbers. 9. Product Code: 0042-0000-UK-L
  • All Serial Numbers. 10. Product Code: 0042-0000-US
  • GTIN: 813502010022
  • All Serial Numbers. 11. Product Code: 0042-0000-US-L
  • All Serial Numbers. 12. Product Code: 0042-0010-AU
  • GTIN: 813502010930

Distribution

Distributed nationwide across the United States.

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