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 | Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactured where the carton sleeve did not match the physical contents of the pack. |
| Product | Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter |
| Quantity | N/A |
| Distribution | OUS only - NL, FR, IT, DE, BE |
| Initiated | 2017-11-28 |
| Classified | 2018-01-14 |
| Terminated | 2020-04-28 |
| Recall number | Z-0347-2018 |
| 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-0347-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78716/
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