FDA Issues Class 1 Recall of Peripheral Stents Due to Complaints of Delivery System Tip Separation

The FDA issued a Class 1 Recall for Zilver PTX Drug-Eluding Peripheral Stents manufactured by Cook Medical due to complaints of delivery system tip separation. All sizes, diameters and lot numbers prior to April 16, 2013 are impacted. According to the FDA, “potential adverse events that may occur in cases where the inner deliver catheter breakage occurs include possible surgery to remove the catheter tip, vascular occlusion due to an unretrieved catheter tip, thrombosis, amputation, possible cardiac arrest, and death.” Read the full safety alert.

Clinical Topics: Arrhythmias and Clinical EP, Invasive Cardiovascular Angiography and Intervention, Implantable Devices, SCD/Ventricular Arrhythmias

Keywords: Amputation, Medical Device Recalls, Catheters, Drug-Eluting Stents, Heart Arrest, Thrombosis

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