Zilver PTX Drug-Eluting Peripheral Stent - 6 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 Preven 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.
FDA Recall Z-1274-2013 · Posted 2013-05-15
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Recalling FirmCook, Inc.
Recall StatusTerminated
Product CodeNIU
Date Initiated2013-04-18
Date Terminated2013-12-05
Product Quantity1,057 units in USA
Reason for Recall
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
Firm Action
Cook Medical sent an Urgent Medical Device Recall letter dated April 24, 2013 to all affect customers. The letter identified the affected products, description of the problem, and actions to be taken. The letter instructed customers to stop use, quarantine, and return all affected products. Customers were asked to complete product reply form and return affected products for credit to Cook Medical, ATTN: Retrun Goods/RGA # 2013C0003. For questions contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - USA Nationwide; in the countries of Japan, Europe, Brazil, and Australia
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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