Recall Z-0347-2018 ยท NRY Catheter, Thrombus Retriever
Stryker Neurovascular
Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
| Date | Nov 28, 2017 |
| 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. |
| Root cause | Packaging process control |
| Action | The affected consignees will be notified via letter sent a courier beginning 11/28/17. A response form has been provided which customers have been asked to complete, and correct affected product is being requested. |
| Distribution | OUS only - NL, FR, IT, DE, BE |
| FDA record | Open on fda.gov |