Cook Medical, Inc Zilver PTX Drug-Eluting Peripheral Stent: Class 1 Recall
MedSun: Newsletter #85, June 2013

FDA MedWatch Safety Alert

Cook Medical received a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter. Potential adverse events may occur in cases where the inner delivery 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.

Additional Information:

Cook Medical, Inc Zilver PTX Drug-Eluting Peripheral Stent: Class 1 Recall. FDA MedWatch Safety Alert. May 24, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm353900.htm


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