Official recall notice
FDA DeviceClass INotable
FDA Recall: Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in
- Recall date
- 2026-04-08
- Brand
- Abiomed, Inc.
- Category
- Medical Device
- FDA class
- Class I
Why it was recalled
Hazard
Increased risk of purge leaks with Generation 1 purge cassettes.
Recommended action
What to do
33,107 units
Product description
Increased risk of purge leaks with Generation 1 purge cassettes.