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

GDC-18 360 ; GDC 360¿ Detachable Coils are intended recalled

Stryker Neurovascular is recalling GDC-18 360 ; GDC 360¿ Detachable Coils are intended for embolization of those, 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 M00334820330, Lot number: 12881100; Exp. Jul 2012.

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-0480-2015
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: Surgical Instruments

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

GDC-18 360 20mm x 33cm ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable

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

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 M00334820330, Lot number: 12881100; Exp. Jul 2012.

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 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.

Other products in this recall event

4 other products · FDA event 69669

This product is part of a recall event; the main page for the event is Gateway OTW; The Gateway PTA balloon catheter is indicated recalled.

Reported	Class	Recall	Company	Reason	Where
10 Dec 2014	CLASS II	Gateway OTW; The Gateway PTA balloon catheter is indicated recalled	Stryker Neurovascular	Other	4 states
10 Dec 2014	CLASS II	Gdc-10 360 Soft SR ; Gdc 360¿ Detachable Coils recalled	Stryker Neurovascular	Other	4 states
10 Dec 2014	CLASS II	GDC-10 360 SR ; GDC 360¿ Detachable Coils are intended recalled	Stryker Neurovascular	Other	4 states
10 Dec 2014	CLASS II	Target 360 Standard recalled by Stryker Neurovascular	Stryker Neurovascular	Other	4 states

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