Zilver 518RX Vascular Stent with Rapid Exchange Delivery System
FDA Recall Z-0689-2016 · Posted 2016-01-22
Recalling FirmCook Medical Incorporated
Recall StatusTerminated
Product CodeNIO
Date Initiated2015-12-22
Date Terminated2017-07-25
Product Quantity753
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
Firm Action
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
Distribution Pattern
Nationwide Worldwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.