FDA Device recall Z-3020-2018
Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE025…
- FDA Device
- Class II
- terminated
- Published 2018-09-19
On 2018-09-19 the FDA classified a Class II recall of Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE025… by Stryker Neurovascular, citing use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3020-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-05 |
| Published | 2018-09-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Neurovascular |
| Distribution | n/a |
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
Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported
Identifiers
| code_info | All lots. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Stryker Neurovascular
- INZONE DETACHMENT SYSTEM, REF: M00345100950
FDA Device · Class II · 2026-07-01 · Stryker Neurovascular - The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end a…
FDA Device · Class II · 2024-10-16 · Stryker Neurovascular - The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip
FDA Device · Class II · 2024-06-12 · Stryker Neurovascular - The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions
FDA Device · Class II · 2024-06-12 · Stryker Neurovascular - The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions
FDA Device · Class II · 2024-06-12 · Stryker Neurovascular
All Stryker Neurovascular recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3020-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.