Wingspan Stent System — Class II medical device recall Z-3020-2018
Terminated recall by Stryker Neurovascular, reported 2018-09-19. Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported
| Recall number | Z-3020-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Neurovascular, Fremont, CA, United States |
| Recall initiated | 2018-06-05 |
| Classified | 2018-09-07 |
| Reported by FDA | 2018-09-19 |
| Terminated | 2020-11-30 |
| Countries outside the US | CN |
| Quantity | 11,585 |
| Model numbers | M003WE0250090, M003WE0250150, M003WE0250200, M003WE0300090, M003WE0300150, M003WE0300200, M003WE0350090, M003WE0350150, M003WE0350200, M003WE0400090, M003WE0400150, M003WE0400200, M003WE0450090, M003WE0450150, M003WE0450200 |
Product
Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450150, M003WE0250200, M003WE0300200, M003WE0350200, M003WE0400200, M003WE0450200
Reason for recall
Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported
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-3020-2018. 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.