Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System — Class II medical device recall Z-0689-2016
Terminated recall by Cook Medical Incorporated, reported 2016-02-03, distributed nationwide. Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently
| Recall number | Z-0689-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Medical Incorporated, Bloomington, IN, United States |
| Recall initiated | 2015-12-22 |
| Classified | 2016-01-22 |
| Reported by FDA | 2016-02-03 |
| Terminated | 2017-07-25 |
| Distributed | Nationwide (US) |
| Quantity | 753 |
| Lot numbers | 518RX |
Product
Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0689-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.