Feb

2022

Recall – Cardiopulmonary bypass system console power interruption, Class I

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

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Recall – Cardiopulmonary bypass system console power interruption, Class I

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