ABIOMED Impella CP Heart Pump Set Introducer Sheath Leakage Risk
ABIOMED is recalling Impella CP heart pump sets worldwide due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines in 14Fr and 23Fr introducers. The manufacturing defect is not visually detectable.
- Product
- ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
- Category
- Medical Device
- Distribution
- Distributed nationwide