Medtronic Perfusion Systems has recalled 316,205 Aortic Root Cannulae, including the DLP and MiAR models, due to the discovery of unexpected loose material inside the device's connector (male luer). This loose material could be introduced into the patient's bloodstream during heart surgery. The recall covers several variations of the product, such as the FlowGuard and Vent Flow models used to manage blood flow and pressure during cardiac procedures.
If the loose material is not identified before the device is used, it could travel through the bloodstream and cause a stroke, which may result in temporary or permanent neurological damage. If the material is discovered before the procedure begins, it can lead to surgical delays while a replacement device is located.
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.
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Sources: FDA iRES · Raw API Response
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