RecallRadar

FDA Device recall Z-0481-2015

Target 360 Standard 12mm x 30cm

On 2014-12-10 the FDA classified a Class II recall of Target 360 Standard 12mm x 30cm by Stryker Neurovascular, citing units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0481-2015
ClassificationClass II
Statusterminated
Initiated2014-10-22
Published2014-12-10
Last updated2026-09-13 11:53 UTC
CompanyStryker Neurovascular
DistributionNH, OH, TX, VA

Product

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

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0481-2015%22

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