Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)

Class I - Dangerous

🏥 Medical Devices Recalled: March 1, 2021 Abiomed Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
Product Code 0042-0000-US UDI-DI 00813502010022; Product Code 0042-0010-US UDI-DI 00813502010985; Product Code 0042-0040-US UDI-DI 00813502011401; Software Versions V8.4 and V8.4.1
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Abiomed, Inc.
Reason for Recall:: Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a pump was not recognized by the AIC.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)

Product Codes/Lot Numbers:

Product Code 0042-0000-US UDI-DI 00813502010022; Product Code 0042-0010-US UDI-DI 00813502010985; Product Code 0042-0040-US UDI-DI 00813502011401; Software Versions V8.4 and V8.4.1

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1175-2024

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