FDA-Device2022-02-09Class I
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.
Abiomed, Inc.
Hazard
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.
Sold states
US distribution to FL, GA, IN, MD, NC, PA, TX.
Affected count
42 Units
Manufactured in
22 Cherry Hill Dr, N/A, Danvers, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0550-2022Don't want to check this manually?
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