Recall Z-0550-2022 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Abiomed, Inc.
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.
| Date | Feb 3, 2022 (initiated Dec 14, 2021) |
| Status | Terminated |
| 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. |
| Root cause | Software design (manufacturing process) |
| Action | The firm began notifying customers by phone starting December 14, 2021. The firm followed up by sending Urgent Medical Device Recall letters to customers on January 20, 2022. The firm is requesting that customers return their devices. The firm does not recommend placing new patients on support. For patients currently on support with an affected system, the firm recommends physicians use their clinical judgement on whether it is appropriate to continue a patient on the OXY-1 System or to transition that patient to the next step in their clinical journey. The letter included instructions on ho |
| Quantity | 42 Units |
| Distribution | US distribution to FL, GA, IN, MD, NC, PA, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200109 | OXY-1 System Abiomed, Inc., Oct 23, 2020 |