Contego Medical LLC is recalling 568 Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon Systems. These medical devices have an integrated filter that may fail to open or may only partially open during a surgical procedure. If the filter does not deploy correctly, it cannot properly protect the patient's brain from debris while the stent is being placed.
A filter that fails to open properly during a carotid artery procedure can lead to debris traveling to the brain, which significantly increases the risk of the patient suffering a stroke or other serious neurological complications. While the recall is voluntary and initiated by the firm, the potential for device failure during use poses a medium safety risk.
REF: NG-0740-140-2
REF: NG-0640-140-2
REF: NG-NV-7-40
REF: NG-NV-6-40
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.
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Sources: FDA iRES · Raw API Response
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