Z-0689-2016 Class II Terminated
FDA device recall Z-0689-2016 was initiated by Cook Medical Incorporated on Dec 22, 2015 and is designated Class II. 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… The recall status is terminated (terminated Jul 25, 2017). Affected quantity: 753.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 3, 2016
- Initiation Date
- Dec 22, 2015
- Termination Date
- Jul 25, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 753
Product Description
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
Distribution Pattern
Nationwide Worldwide
Code Information
Catalog Prefix ZIVX5. All Lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0689-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026