OXY-1 System Console Experiences Power Interruption During Use
OXY-1 System consoles used during cardiac support procedures may experience power interruptions that disrupt patient therapy, potentially causing prolonged oxygen deprivation.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. Per the rubric, FDA Class I recalls receive a minimum severity score of 4. The power interruption of a critical-care cardiac support device creates substantial risk of patient harm through therapy disruption and hypoxia.
Plain-English summary
The FDA has issued a Class I recall for the OXY-1 System (Model 001-0500-001) manufactured by Abiomed, Inc. This system provides cardiac support during cardiopulmonary bypass procedures. Forty-two units have been affected and are distributed to hospitals in Florida, Georgia, Indiana, Maryland, North Carolina, Pennsylvania, and Texas.
The OXY-1 System Console has experienced power interruptions during patient use. These power failures interrupt the delivery of critical therapy. When therapy is disrupted during cardiac support, patients may experience prolonged hypoxia—a dangerous lack of oxygen to body tissues. This could result in serious harm to patients.
Healthcare providers using affected units should contact Abiomed, Inc. for guidance on remediation or device replacement. Specific serial numbers and software versions have been identified in this recall. Patients and caregivers should be aware of this safety issue if they are receiving or have received treatment with this device.
The recalled product
- 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.
- Manufacturer
- Abiomed, Inc.
- Category
- Medical Device — Cardiac Support
- Hazard
- power-interruption
- therapy-disruption
- hypoxia-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI 00860001797909 Software Version Number V-1.3.15.0
Distribution
Distributed in 7 states:
- FL
- GA
- IN
- MD
- NC
- PA
- TX
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