Company: Abiomed, Inc.
Date of Enforcement Report: 2/9/2022
Class I
PRODUCT
OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number 001-0400-100 is sold separately and is not part of this recall.
Recall Number:
Z-0550-2022
REASON
The firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use, which disrupts therapy delivered to a patient on support. Disruption of therapy could lead to prolonged hypoxia.
RECALLING FIRM/MANUFACTURER
Abiomed, Inc. on 12/14/2021. Voluntary: Firm initiated
VOLUME OF PRODUCT IN COMMERCE
42 Units
DISTRIBUTION
U.S. Nationwide and International