Abiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
Abiomed is recalling the Impella CP Smart Assist Set due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines in 14Fr and 23Fr introducers. These manufacturing issues are not visually detectable.
- Product
- ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
- Category
- Medical Device
- Distribution
- Distributed nationwide