Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator Recalled by Maquet Cardiovascular Us Sales, Llc Due to It has come to firm's attention that, in...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Maquet Cardiovascular Us Sales, Llc directly.
Affected Products
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The devices utilization period is limited to six hours.
Quantity: 23,203 units
Why Was This Recalled?
It has come to firm's attention that, in some rare cases, the blood outlet connector on some models of MAQUET Oxygenators may detach from the oxygenator. This event has occurred in about 0.01% (1:10,000) of units shipped.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Maquet Cardiovascular Us Sales, Llc
Maquet Cardiovascular Us Sales, Llc has 62 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report