CLASS II Device recall · Reported 10 Dec 2014 · FDA Enforcement Report

Target 360 Standard recalled by Stryker Neurovascular

Stryker Neurovascular is recalling Target 360 Standard, distributed in New Hampshire, Ohio, Texas, Virginia. The recall was initiated on 22 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel M0035461230, Lot number: 13817326; Exp. Oct 2013.

Quantity recalled1 unit

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-0481-2015
FDA event ID: 69669
Recalling firm: Stryker Neurovascular, Fremont, CA
Classification: Class II
Status: Terminated
Recall initiated: 22 Oct 2014
FDA classified: 28 Nov 2014
Reported: 10 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

22 Oct 2014	Recall initiated by company
28 Nov 2014	Classified by FDA	+37 days
10 Dec 2014	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

Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.

Product as listed by the FDA

Target 360 Standard 12mm x 30cm; Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Target Detachable Coils are indicated for endovascular embolization of: " Intracranial aneurysms " Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae " Arterial and venous embolizations in the peripheral vasculature

Where it was distributed

US Distribution to the states of: VA, NH, OH and TX.

New Hampshire Ohio Texas Virginia

Stores named: Target

Questions about this recall

Is Target 360 Standard recalled?

Yes. Stryker Neurovascular recalled Target 360 Standard on 22 Oct 2014. The recall is Class II and its status is Terminated. Recall number Z-0481-2015.

Why was it recalled?

Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.

Which lots are affected?

Model M0035461230, Lot number: 13817326; Exp. Oct 2013.

Where was it sold?

US Distribution to the states of: VA, NH, OH and TX.

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 21 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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