FDA adds to recall warning over Zilver PTX stent (Cook Medical) for PAD
The FDA has added a serious warning to Cook Medical's recall of its Zilver PTX paclitaxel eluting stent for PAD. The recall was ordered on April 18 2013, soon after the device received FDA approval. 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 that may occur in cases where the inner deliver catheter breakage occurs include possible surgery to remove the catheter tip. However the upgraded Class 1 recall warning states that problems with the Zilver's delivery catheter could lead to thrombosis, amputation or death.
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