Maquet Medical Systems USA is recalling approximately 2,180 RotaFlow Centrifugal Pumps with BIOLINE and SOFTLINE coatings (Product Codes 701047554 and 701047553) because defects in the packaging seals could compromise the sterile barrier. These pumps are critical components used in cardiovascular bypass circuits to circulate blood outside the body during surgery or life support. If the sterile barrier is breached, the devices may become contaminated with harmful germs before they are used on a patient. Consumers should immediately contact the manufacturer or their healthcare provider for specific instructions on managing affected units.
A breach of the sterile barrier can expose patients directly to pathogenic agents during medical procedures. This exposure poses a significant risk of internal inflammation, serious infection, or life-threatening sepsis.
Contact manufacturer for instructions
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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