Recall Z-0021-2025 ยท QJP Catheter, Percutaneous, Neurovasculature
Stryker Neurovascular
The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapte
| Date | Oct 7, 2024 (initiated Aug 30, 2024) |
| Status | Open, Classified |
| Reason | Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed to customers in the US. |
| Root cause | Under Investigation by firm |
| Action | On 09/12/2024, the firm sent via FedEx an "URGENT: MEDICAL DEVICE RECALL - Customer Notification" Letter to customers informing them that certain lots of Trevo Trak 21 Microcatheters were shipped with the incorrect configuration. The affected products contained Instructions for Use (IFUs) and product labels for international use, instead of the United States (US). The International IFUs contain intended uses that have not been cleared/approved for the U.S. market. Customer are instructed to: 1. Immediately check internal inventory for affected devices. 2. When using impacted lot(s) of Trevo |
| Quantity | 6 |
| Distribution | U.S. Nationwide distribution in the states of CA and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211594 | Trevo Trak 21 Microcatheter Stryker Neurovascular, Nov 26, 2021 |