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Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System

FDA Recall #Z-0689-2016 — Class II — December 22, 2015

Recall #Z-0689-2016 Date: December 22, 2015 Classification: Class II Status: Terminated

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

Recalling Firm

Cook Medical Incorporated — Bloomington, IN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

753

Distribution

Nationwide Worldwide

Code Information

Catalog Prefix ZIVX5. All Lots

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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