FDA Device recall Z-0689-2016
Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
- FDA Device
- Class II
- terminated
- Published 2016-02-03
On 2016-02-03 the FDA classified a Class II recall of Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System by Cook Medical, citing 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. Fa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0689-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-22 |
| Published | 2016-02-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cook Medical |
| Distribution | US |
Product
Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
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
Identifiers
| code_info | Catalog Prefix ZIVX5. All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0689-2016%22
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