ABIOMED Impella 5.5 Heart Pump Introducer Sheath Leakage Risk Recall
Abiomed is recalling the Impella 5.5 Smart Assist Set heart pump due to potential leakage from introducer sheaths. The defect is not visually detectable and affects all affected pump sets worldwide.
- Product
- ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
- Category
- Medical Device
- Distribution
- Distributed nationwide