Class II — Stryker Neurovascular
| Recalling firm | STRYKER CORP. |
|---|---|
| Registered facility | View this company's 61 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date. |
| 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 |
| Quantity | 1 unit |
| Distribution | US Distribution to the states of: VA, NH, OH and TX. |
| Initiated | 2014-10-22 |
| Classified | 2014-11-28 |
| Terminated | 2015-02-12 |
| Recall number | Z-0480-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Stryker Neurovascular (Z-0480-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69669/
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