Air Embolism Risk Leads to Recall of Guardian II Hemostasis Valves
The potential threat of an air embolism has prompted Vascular Solutions to announce the recall of Guardian II NC and Guardian II Hemostasis Valves available between February of last year and this past February. The recall encompasses four separate model numbers: 8215, 8216, 8210, and 8211. These particular models could suffer from a defect that allows air to leak into the device in the midst of a procedure. This can lead the patient to experience an embolism that could cause serious injuries or a fatality. Used during catheterizations to cut down on the attendant loss of blood that can be a side effect of said procedures, the devices should not be used on patients. Steps should also be taken to ensure the Hemostasis Valves don’t accidentally get used.
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