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.
Check against the official notice below — it lists the full affected range.
Abiomed, Inc. is recalling the OXY-1 System Console, a device used during cardiopulmonary bypass procedures. The company received complaints that the Console experienced power interruptions while in use, which disrupted therapy being delivered to patients. When therapy is disrupted, patients can experience prolonged hypoxia, a condition where the body does not get enough oxygen.
The recall affects 42 units distributed in Florida, Georgia, Indiana, Maryland, North Carolina, Pennsylvania, and Texas. The affected devices have specific serial numbers and software versions (V-1.3.15.0, V-1.4.6.0, and V.1.4.8.0). The record does not specify what remedy an affected consumer should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US distribution to FL, GA, IN, MD, NC, PA, TX. Quantity: 42 Units Lot/code info: UDI 00860001797909 Software Version Number V-1.3.15.0, V-1.4.6.0 and V.1.4.8.0 Serial Numbers 20200231-04 20200249-01 20200249-05 20200309-02 20200339-01 20200339-03 20200352-01 20200442-01 20200442-02 20200442-05 20210768-01 20210795-02 20210870-01 20210880-01 20210890-01 20210894-01 20210895-01 20210896-01 20210897-01 20210795-04
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.