GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile — Class II medical device recall Z-1516-2016
Terminated recall by Stryker Neurovascular, reported 2016-04-27, distributed nationwide. The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.
| Recall number | Z-1516-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Neurovascular, Fremont, CA, United States |
| Recall initiated | 2016-03-21 |
| Classified | 2016-04-19 |
| Reported by FDA | 2016-04-27 |
| Terminated | 2016-07-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, CH, CY, CZ, DE, ES, FR, HK, IN, IT, MX, NL, RU, SA, SE, TR, UA, UY |
| Quantity | 316 total |
| Reason classes | device malfunction |
| Lot numbers | 17074659, 17581672, 18617200 |
| Model numbers | M0033471020SR0 |
Product
GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033471020SR0; Neurology: GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that because of their morphology, their location, or the patients 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
The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.
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-1516-2016. 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.