Medtronic Inc. is recalling one unit of the Protege GPS Self-Expanding Peripheral Stent System (product number SERB65-09-60-80) because defects in the packaging seal may prevent the device from remaining sterile. A compromised seal can allow bacteria or other contaminants to enter the packaging before the device is used in a medical procedure. This recall affects a single unit distributed in Minnesota with lot number B644679.
If a non-sterile stent is implanted into a patient, it can cause serious infections or other health complications because the device comes into direct contact with the bloodstream. No injuries have been reported specifically for this single-unit event.
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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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