Recall Z-3020-2018 ยท NJE Intracranial Neurovascular Stent
Stryker Neurovascular
Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450150, M003WE0250200, M003WE0300200, M003WE0350200, M003WE0400200, M003WE0450200
| Date | Jun 5, 2018 |
| Status | Terminated |
| Reason | Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported |
| Root cause | Use error |
| Action | On 06/05/2018 Urgent Medical Device Voluntary Customer Notification letters were sent to consignees via courier restating information present in the Directions for Use and additional information. Consignees were instructed to complete Acknowledgement Forms acknowledging receipt and review of the customer notification. |
| Quantity | 11585 |
| Distribution | China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.