Spectrum Medical Ltd. is recalling 172 units of its Quantum Perfusion Systems (Roller Pumps) used during cardiopulmonary bypass procedures. The recall was initiated because certain internal components (ratchet and pawl) were manufactured with incorrect geometry, which prevents the left bobbin from locking properly. This mechanical defect affects products with catalog numbers 51-000013-00 and 51-000008-00 and was distributed across several U.S. states. Consumers should be aware that this is a voluntary, firm-initiated recall and involves specific serial numbers distributed between 2023 and 2024.
If the pump bobbin fails to lock during a medical procedure, it may lead to an interruption in blood flow or inconsistent delivery of blood through the venous and arterial circuits. This malfunction could pose a serious health risk to patients undergoing bypass surgery who rely on the pump for life-sustaining circulation.
Firm initiated visit for remediation.
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
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.