HIGH

Abiomed Recalls Automated Impella Controller Due to Cybersecurity Risks

Abiomed issued a recall for 10,153 Automated Impella Controllers on October 1, 2025. The devices face potential cybersecurity vulnerabilities related to their operating system. Healthcare providers and patients should stop using these devices immediately.

Quick Facts at a Glance

Recall Date
October 1, 2025
Hazard Level
HIGH
Brand
Abiomed
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abiomed, Inc. or your healthcare provider for instructions. Notification method: Letter

Product Details

The recall involves multiple models of the Automated Impella Controller, including product codes 0042-0000-AU, 0042-0000-CA, 0042-0000-EU, and others. The devices were distributed nationwide and internationally, including in Europe and Asia.

The Hazard

The recall stems from potential cybersecurity vulnerabilities that could compromise the functionality of the Automated Impella Controller. This risk is classified as Class I, indicating a high hazard level.

Reported Incidents

As of the report date, no injuries or incidents related to this issue have been reported. The company has taken this precautionary measure to ensure patient safety.

What to Do

Patients and healthcare providers should stop using the device immediately. Contact Abiomed, Inc. or your healthcare provider for further instructions and details on the recall.

Contact Information

For additional information, contact Abiomed at 1-800-422-8666 or visit their website at https://www.abiomed.com.

Key Facts

  • 10,153 units recalled
  • Potential cybersecurity risks
  • Class I recall
  • No reported injuries
View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeAutomated Heart Pump Controller
Sold At
Multiple Retailers

Product Details

Brand
Abiomed
Model Numbers
0042-0000-AU
0042-0000-CA
0042-0000-EU
0042-0000-EU-L
0042-0000-IN
+27 more
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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