MicroVention Inc. is recalling approximately 467 units of FRED 27 and FRED X 27 Flow Re-Direction Endoluminal Devices due to a manufacturing issue. The defect involves the length or attachment pattern of the tantalum markers, which may prevent the device from opening fully or fitting correctly against the vessel wall during surgical procedures. If the device does not open properly, surgeons may need to recapture and remove both the delivery system and the microcatheter together.
If the device fails to open completely or fits poorly against the vessel wall, it may not function as intended, potentially leading to long-term health consequences or requiring additional surgical interventions. No specific injuries were reported in the recall data, but the failure of an implanted device to properly appose to a vessel wall poses a moderate risk to patient safety.
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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