FDA Device recall Z-0480-2015
GDC-18 360 20mm x 33cm
- FDA Device
- Class II
- terminated
- Published 2014-12-10
On 2014-12-10 the FDA classified a Class II recall of GDC-18 360 20mm x 33cm 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
| Agency | FDA Device |
|---|---|
| Recall number | Z-0480-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-22 |
| Published | 2014-12-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Neurovascular |
| Distribution | NH, OH, TX, VA |
Product
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
Reason
Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
Identifiers
| code_info | Model M00334820330, Lot number: 12881100; Exp. Jul 2012. |
|---|
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-0480-2015%22
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