medical Class II Updated 2023-12-13

Abiomed, Inc. recalls Automated Impella Controller (AIC), product number 0042-040-

Recalled Product

Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.

Hazard / Issue

Pump not detected as connected to controller due to software issue.

Issued by

FDA

Affected States: AZ, CA, FL, NY, VA
Lot/Code Info: UDI-DI (GTIN): 00813502011401, serial numbers IC8386, IC8391 and IC8617.
View official government recall

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