Class II — Cook Medical Incorporated
| Recalling firm | COOK MEDICAL |
|---|---|
| Registered facility | COOK MEDICAL LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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 |
| Product | Zilver® 518RX Vascular Stent with Rapid Exchange Delivery System |
| Quantity | 753 |
| Distribution | Nationwide Worldwide |
| Initiated | 2015-12-22 |
| Classified | 2016-01-22 |
| Terminated | 2017-07-25 |
| Recall number | Z-0689-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cook Medical Incorporated (Z-0689-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72965/
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