Home / Recalls / Medical Devices
Abiomed, Inc. recalls OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pum
Recalled February 9, 2022 · FDA recall Z-0550-2022 · Abiomed
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. · FDA Class I
Units
42 Units
Sold at
US distribution to FL, GA, IN, MD, NC, PA, TX.
Description
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.
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.
Manufacturer(s)
Abiomed, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →