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

Heart pump controller recalled for operating system cybersecurity vulnerabilities

Abiomed is recalling Automated Impella Controller (AIC) devices due to potential cybersecurity vulnerabilities in the operating system. Approximately 10,153 units have been distributed nationwide and internationally.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification requires a minimum severity score of 4 per the severity rubric. The device provides critical heart support functionality, making cybersecurity vulnerabilities in its operating system a serious concern.

Plain-English summary

Abiomed, Inc. is recalling the Automated Impella Controller (AIC), a medical device used to provide left heart support as a blood pump. The device assists with blood circulation in patients requiring cardiac support.

The recall is due to potential cybersecurity vulnerabilities related to the operating system in the device. The FDA has classified this as a Class I recall, the agency's most serious classification.

The affected devices include all serial numbers across various configurations, including standard Impella Controllers, Impella Optical Controllers, and versions with Impella Connect and remote link capabilities. Approximately 10,153 units have been distributed nationwide and internationally to countries including Canada, the United Kingdom, Europe, Japan, India, Australia, and others.

Patients and healthcare providers should contact Abiomed for information on available remediation options and any necessary updates or protective measures.

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 — Cardiac Support
Hazard
  • cybersecurity-vulnerability

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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