Maquet Cardiovascular, LLC has recalled 40,928 units of the Heartstring III Proximal Seal System because the device may fail to load, fail to deploy into the aorta, or fail to provide a proper seal during cardiac surgery. These failures can result in excessive bleeding or clinical complications for the patient. Clinicians and hospitals are advised to identify affected units using the model and serial numbers and to stop using them immediately.
If the seal fails to deploy or provide adequate blood flow control, it can cause significant bleeding during surgical procedures, potentially requiring additional medical intervention or causing serious patient harm.
Quantity: 126 units (91 US, 35 OUS)
Quantity: 28,331 units (16,615 US, 11,716 OUS)
Quantity: 12,471 units (6,565 US, 5,906 OUS)
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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