Abiomed recalls OXY-1 System Model 001-0500-001 used in cardiopulmonary bypass due to power interruptions causing therapy disruption and potential prolonged hypoxia. Affected units have specific serial numbers and software versions.
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.
Abiomed is recalling its OXY-1 System Model 001-0500-001 used during heart-lung bypass surgery because power interruptions can disrupt therapy, potentially causing prolonged low oxygen levels in patients. This recall affects specific units with listed serial numbers and software versions.
The OXY-1 System Console can experience power interruptions during use, which disrupts the oxygen therapy delivered to patients. This disruption may lead to prolonged hypoxia (low oxygen levels) in patients on support, potentially causing serious health complications.
Healthcare professionals using the OXY-1 System during cardiopulmonary bypass procedures are most at risk. Patients receiving the system during surgery could experience prolonged hypoxia if the power interruption occurs.
Check if your OXY-1 System has the model number 001-0500-001 and serial numbers listed in the recall notice (e.g., 20200231-04, 20200249-01). Also verify the software version is V-1.3.15.0, V-1.4.6.0, or V-1.4.8.0.
Verify your OXY-1 System model number and serial numbers match those listed in the recall notice.
Reach out to Abiomed directly for guidance on next steps if your unit is affected.
The recall affects the OXY-1 System used during cardiopulmonary bypass procedures. If your surgery uses this specific model, it may be affected.
Check if your OXY-1 System has the model number 001-0500-001 and serial numbers listed in the recall notice (e.g., 20200231-04, 20200249-01). Also verify the software version is V-1.3.15.0, V-1.4.6.0, or V-1.4.8.0.
Contact Abiomed directly to confirm if your unit is affected and receive guidance on next steps.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-0550-2022 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-0550-2022 from Abiomed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
