FDA-Device2022-02-09Class I
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.
Hazard
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.
Sold states
US distribution to FL, GA, IN, MD, NC, PA, TX.
Affected count
42 Units
Manufactured in
22 Cherry Hill Dr, N/A, Danvers, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0550-2022More Abiomed, Inc. recalls
- FDA-Device2026-07-01Abiomed Impella CP Set with SmartAssist recalled for blood clot risk during prolonged use
- FDA-Device2026-07-01Abiomed Impella CP Low Profile Introducer Kit recalled for blood clot risk
- FDA-Device2026-07-01Abiomed Impella CP Low Profile Introducer Kit recalled for blood clot risk
- FDA-Device2026-07-01Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
- FDA-Device2026-06-24Abiomed Impella CP Set with SmartAssist recalled for mechanical support interruption risk
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