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

FDA device recall Z-1274-2013 · posted 2013-05-15 · Terminated

Recall details

Recalling firm

Cook, Inc.

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

Action taken

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

Status

Terminated

Product code

NIU

Quantity affected

1,057 units in USA

Distribution

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

Date initiated

2013-04-18

Date posted

2013-05-15

Date terminated

2013-12-05

Location

Bloomington, IN