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U.S. Department of Health and Human Services

Class 2 Device Recall Zilver 518RX Vascular Stent

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  Class 2 Device Recall Zilver 518RX Vascular Stent see related information
Date Initiated by Firm December 22, 2015
Date Posted January 22, 2016
Recall Status1 Terminated 3 on July 25, 2017
Recall Number Z-0689-2016
Recall Event ID 72965
PMA Number P050017S004 
Product Classification Stent, iliac - Product Code NIO
Product Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
Code Information Catalog Prefix ZIVX5. All Lots
Recalling Firm/
Manufacturer		 Cook Medical Incorporated
400 N Daniels Way
Bloomington IN 47404-9155
For Additional Information Contact Cook Medical Customer Relations Departme
800-457-4500
Manufacturer 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
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 753
Distribution Nationwide Worldwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = NIO and Original Applicant = Cook Ireland, Ltd.
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