CLASS II Device recall · Reported 3 Feb 2016 · FDA Enforcement Report

Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System recalled

Cook Medical is recalling Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System, distributed nationwide in the US. The recall was initiated on 22 Dec 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Prefix ZIVX5. All Lots

Quantity recalled753

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0689-2016
FDA event ID: 72965
Recalling firm: Cook Medical, Bloomington, IN
Classification: Class II
Status: Terminated
Recall initiated: 22 Dec 2015
FDA classified: 22 Jan 2016
Reported: 3 Feb 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

22 Dec 2015	Recall initiated by company
22 Jan 2016	Classified by FDA	+31 days
3 Feb 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System

Where it was distributed

Nationwide Worldwide

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Catalog Prefix ZIVX5. All Lots

Where was it sold?

Nationwide Worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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