GDC-18 360 20mm x 33cm — Class II medical device recall Z-0480-2015
Terminated recall by Stryker Neurovascular, reported 2014-12-10, distributed in NH, OH, TX, VA. Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the e
| Recall number | Z-0480-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Neurovascular, Fremont, CA, United States |
| Recall initiated | 2014-10-22 |
| Classified | 2014-11-28 |
| Reported by FDA | 2014-12-10 |
| Terminated | 2015-02-12 |
| Distributed | NH, OH, TX, VA |
| Quantity | 1 units |
| Lot numbers | 12881100 |
| Model numbers | M00334820330 |
| Expiration dates | 2012-07-20 |
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 for recall
Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0480-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.