FDA DeviceClass INotable

FDA Recall: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Intro

Date: 2026-07-01
Brand: Abiomed, Inc.
Category: Medical Device
FDA Class: Class I

Description

Potential for thrombus formation during prolonged use of the introducer.

Hazard

Potential for thrombus formation during prolonged use of the introducer.

Remedy

168 units

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