Recall archive / FDA device enforcement
OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump D... — FDA record Z-0550-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 14, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- 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.
- Classification
- Class I
- Recalling firm
- Abiomed, Inc.
- Quantity
- 42 Units
- Agency-reported status
- Terminated
- Source record identifier
- Z-0550-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to FL, GA, IN, MD, NC, PA, TX.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Feb 9, 2022
- Recall initiation date
- Dec 14, 2021
- Center classification date
- Feb 3, 2022
- Termination date
- Feb 28, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.