ABIOMED Intro Kit Heart Pump Introducer Sheath Leakage Risk
Abiomed, Inc. is recalling ABIOMED Intro Kit heart pump introducer sheaths due to potential leakage from under the sheath cap and along hub score lines. The manufacturing defects are not visually detectable by users.
- Product
- ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
- Category
- Medical Device
- Distribution
- Distributed nationwide