Recall Z-1275-2013— Cook, Inc.

Class I FDA medical device recall by Cook, Inc., initiated 2013-04-18, terminated 2013-12-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoropopliteal artery). The Paclitaxel coating helps prevent the artery from narrowing again (restenosis). The Zilver; PTX stent acts as a scaffold to: Hold open a narrowed artery in the thigh (femoropopliteal artery) caused by PAD. Improve blood flow to the extremity.. Reason: Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events, including one death, occurred in cases where a tip separation.

Recalling firm

Cook, Inc.

Classification

Class I

Status

Terminated

Initiated

2013-04-18

Terminated

2013-12-05

Firm location

Bloomington, IN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.