FDA DeviceClass INotable

FDA Recall: Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434.

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

3 units

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