Z-1274-2013Class I

Zilver PTX Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile

Name: Z-1274-2013 Zilver PTX Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile
Creator: Cook, Inc.
Published: 2013-04-18
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2013-04-18 / Terminated / root cause: manufacturing process

FDA source

Cook, Inc. began a recall of 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... on 2013-04-18. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1274-2013
Classification: Class I
Status: Terminated
Initiated: 2013-04-18
Posted: 2013-05-15
Terminated: 2013-12-05
Recalling firm: Cook Incorporated
Product: 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.
Product code: NIU Stent, Superficial Femoral Artery, Drug-Eluting
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
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 1,057 units in USA
Distribution: Worldwide Distribution - USA Nationwide; in the countries of Japan, Europe, Brazil, and Australia
Product codes and lots: REF ZIV6-35-125-6-80-PTX ; REFG24890 UDI 10827002248905 All lots distributed prior to 4/16/2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1274-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1274-2013	Class I	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-15
Z-1275-2013	Class I	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-15

Product code NIU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)