Z-0689-2016Class II

Zilver 518RX Vascular Stent with Rapid Exchange Delivery System

Name: Z-0689-2016 Zilver 518RX Vascular Stent with Rapid Exchange Delivery System
Creator: Cook Medical Incorporated
Published: 2015-12-22
License: https://open.fda.gov/license/

Cook Medical LLC / initiated 2015-12-22 / Terminated / root cause: design

FDA source

Cook Medical Incorporated began a recall of Zilver 518RX Vascular Stent with Rapid Exchange Delivery System on 2015-12-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0689-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-22
Posted: 2016-01-22
Terminated: 2017-07-25
Recalling firm: Cook Medical LLC
Product: Zilver 518RX Vascular Stent with Rapid Exchange Delivery System
Product code: NIO Stent, Iliac
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
Root cause tag: design
FDA root cause: 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
Product codes and lots: Catalog Prefix ZIVX5. All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0689-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0689-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-03	2016-01-22

Product code NIO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)