Cook, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1275-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: April 18, 2013

Date Posted: May 22, 2013

Recall Number: Z-1275-2013

Event ID: 64975

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

Status: Terminated

Product Quantity: 535 units in USA

Code Information:

REF ZIV6-35-125-7-80-PTX ; UDI 10827002248950 all lots distributed through 4/16/13

Distribution Pattern:

Worldwide Distribution - USA Nationwide; in the countries of Japan, Europe, Brazil, and Australia

Voluntary or Mandated:

Voluntary: Firm initiated