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U.S. Department of Health and Human Services

Class 1 Device Recall OXY1 System for extracorporeal circulation

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  Class 1 Device Recall OXY1 System for extracorporeal circulation see related information
Date Initiated by Firm December 14, 2021
Date Posted February 03, 2022
Recall Status1 Terminated 3 on February 28, 2023
Recall Number Z-0550-2022
Recall Event ID 89328
510(K)Number K200109  
Product Classification Oxygenator, cardiopulmonary bypass - Product Code DTZ
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.
Code Information 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
Recalling Firm/
Manufacturer		 Abiomed, Inc.
22 Cherry Hill Dr
Danvers MA 01923-2575
For Additional Information Contact Mr. Ralph Barisano
978-646-1400
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 42 Units
Distribution US distribution to FL, GA, IN, MD, NC, PA, TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DTZ and Original Applicant = Abiomed Inc.
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