FDA DeviceClass INotable

FDA Recall: Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.

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

Description

Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.

Hazard

Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.

Remedy

10 units

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