FDA Medical Device Recalls (openFDA)
Cook Medical Incorporated: Zilver 518RX Vascular Stent with Rapid Exchange Delivery System
- Recall number
- Z-0689-2016
- Recalling firm
- Cook Medical Incorporated
- Product
- Zilver 518RX Vascular Stent with Rapid Exchange Delivery System
- Status
- Terminated
- Initiated
- 2015-12-22
- Posted
- 2016-01-22
- Terminated
- 2017-07-25
- Reason
- 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
- 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
- 753
- Distribution
- Nationwide Worldwide
- Lot, serial or model codes
- Catalog Prefix ZIVX5. All Lots
- 510(k) numbers
- not on file
- PMA numbers
- ["P050017S004"]
- Product code
- NIO
- Firm FEI
- 3005580113
- Firm city
- Bloomington
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28