FDA DeviceClass INotable

FDA Recall: Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1

Date: 2026-04-08
Brand: Abiomed, Inc.
Category: Medical Device
FDA Class: Class I

Description

Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.

Hazard

Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.

Remedy

62 units

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