OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Driv

FDA device recall Z-0550-2022 · posted 2022-02-03 · Terminated

Recall details

Recalling firm

Abiomed, Inc.

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.

Action taken

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.

Root cause

Software design (manufacturing process)

Status

Terminated

Product code

DTZ

Quantity affected

42 Units

Distribution

US distribution to FL, GA, IN, MD, NC, PA, TX.

Date initiated

2021-12-14

Date posted

2022-02-03

Date terminated

2023-02-28

Location

Danvers, MA

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