FDA DeviceClass INotable

FDA Recall: Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the foll

Date: 2026-06-24
Brand: Abiomed, Inc.
Category: Medical Device
FDA Class: Class I

Description

Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.

Hazard

Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.

Remedy

10,297 units

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