Trevo Trak Microcatheter (Stryker) – Packaging Label Issue (2024)
Incorrect product labeling may cause potential documentation misunderstandings.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 adapter is provided with each microcatheter.
Brand
Stryker Neurovascular
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Model/Catalog Number: 90338 UDI Codes: (01)07613327313956(17)251125(10)0000590444 (01)07613327313956(17)260101(10)0000603275 Lot Numbers: 0000590444 0000603275
Stryker Neurovascular is recalling The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with r due to Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and ca. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 Trak 21 Microcatheters, follow the US IFU attached in this communication NV00055463-02 (Attachment A) instead of the one that originally came with the device. 3. Circulate recall notification internally to all interested/affected parties and post this customer notification on or near affected products. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. 5. Inform Stryker Neurovascular if the subject devices have been distributed to other organizations and provide contact details so that Stryker Neurovascular can inform the recipients appropriately. 6. Inform Stryker Neurovascular of any adverse events concerning the use of the subject devices. (US Customer Service: 1-855-91-NEURO (1-855-916- 3876), Email: NVCustomerCare@stryker.com). 7. Complete the attached customer response form. It may be that you no longer have any physical inventory on site. Completing this form allow for updating records and will also negate the need to send any further unnecessary communications on this matter. 8. Email the completed form to nvfieldactions@stryker.com. Contact the local Stryker representative, send an email to nvfieldactions@stryker.com or call US Customer Service: 1-855-91-NEURO (1-855-916-3876) for further assistance related to this Medical Device Recall Customer Notification.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026