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The U.S. Food and Drug Administration (FDA) has issued a class I recall for the Advance Enforcer 35 Focal-Force PTA Balloon Catheter 6mm x 4cm, manufactured by Cook Incorporated, due to “multiple complaints” regarding a high recurrence rate of balloons bursting below the rated burst pressure. According to the Agency, potential implications for using an affected product may include “delay in the procedure, additional intervention, vessel injury, balloon fragmentation in the patient, and death.” The recall impacts models 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248; 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252; and 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35257.

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