Zilver 518RX Vascular Stent with Rapid Exchange Delivery System

FDA device recall Z-0689-2016 · posted 2016-01-22 · Terminated

Recall details

Recalling firm

Cook Medical Incorporated

Reason for recall

Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications, and the joint may separate during deployment. Failure of this joint during a procedure may result in a partial stent deployment. The clinical effect of a partial deployment may be a need for surgical intervention, or may result in vessel trauma or an embolic event

Action taken

Cook Medical sent an "URGENT: MEDICAL DEVICE RECALL" letter dated December 22, 2015, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235. On 2/5/2016 a second recall notification was sent to affected consignees, expanding the recall to All Lots of the affected product.

Root cause

Device Design

Status

Terminated

Product code

NIO

Quantity affected

753

Distribution

Nationwide Worldwide

Date initiated

2015-12-22

Date posted

2016-01-22

Date terminated

2017-07-25

Location

Bloomington, IN