Agency classClass IOur severity:Severe FDA (Devices)·Z-0550-2022·Announced 2022-02-09

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Affected units: 42

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:

Same manufacturer · Abiomed, Inc.

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Same hazard · power interruption