Recall Z-1084-2024 ยท DQO Catheter, Intravascular, Diagnostic
Stryker, Inc.
Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm
| Date | Feb 14, 2024 (initiated Dec 6, 2023) |
| Status | Open, Classified |
| Reason | The microcatheter IFU contains an intended use that has not been evaluated by the FDA. |
| Root cause | Under Investigation by firm |
| Action | On December 22, 2023, Stryker Neurovascular issued a "Urgent: Medical Device Recall" notification to affected consignees. Stryker asked consignees to take the following actions: Immediately check your internal inventory for affected devices. 2. The affected items may continue to be used. 3. When using impacted lot(s) of Trevo Trak 21 or Trevo Pro 18 microcatheter, please follow the IFU attached in this communication instead of the one that originally came with the device. 4. Circulate this Customer Notification internally to all interested/affected parties. 5. Maintain awareness of this commu |
| Quantity | 11 units |
| Distribution | US Nationwide distribution in the states of AL, FL, GA, HI, IL, MI, NC, NH, OH, PA, TX, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131437 | MODIFIED CONCENTRIC MICROCATHETER Concentric Medical, Inc., Oct 11, 2013 |