Recall Z-0550-2022— Abiomed, Inc.
Class I · Terminated
Class I FDA medical device recall by Abiomed, Inc., initiated 2021-12-14, terminated 2023-02-28. It names one FDA 510(k) clearance: K200109. 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..
- Recalling firm
- Abiomed, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2021-12-14
- Terminated
- 2023-02-28
- Firm location
- Danvers, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.