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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Abiomed, Inc.
Lot Codes / Batch Numbers
UDI 00860001797909 Software Version Number V-1.3.15.0
Products Sold
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
Abiomed, Inc. is recalling OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consis due to The firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use, which disrupts therapy delivered to a pat. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 how to return impacted product. If you have questions on returning product, If you have any questions, please contact Diane Welsh from Abiomed s customer service team at (978) 646-1467 or email customerservice@abiomed.com. The firm's Clinical field staff will be available to coordinate boxing and shipping of the OXY-1 system for return to Abiomed. If you have questions regarding this recall, please contact Ralph Barisano directly at (978) 882-8068.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, GA, IN, MD, NC, PA, TX
Page updated: Jan 10, 2026