Z-1274-2013 Class I Terminated
FDA device recall Z-1274-2013 was initiated by Cook, Inc. on Apr 18, 2013 and is designated Class I. 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… The recall status is terminated (terminated Dec 5, 2013). Affected quantity: 1,057 units in USA.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2013
- Initiation Date
- Apr 18, 2013
- Termination Date
- Dec 5, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,057 units in USA
Product Description
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.
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
Distribution Pattern
Worldwide Distribution - USA Nationwide; in the countries of Japan, Europe, Brazil, and Australia
Code Information
REF ZIV6-35-125-6-80-PTX ; REFG24890 UDI 10827002248905 All lots distributed prior to 4/16/2013
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1274-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026