FDA DeviceClass INotable

FDA Recall: Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in

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

Description

Increased risk of purge leaks with Generation 1 purge cassettes.

Hazard

Increased risk of purge leaks with Generation 1 purge cassettes.

Remedy

33,107 units

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