Trevo Trak 21 Microcatheter (Stryker) – Unapproved Use (2023)
Microcatheter instructions contain an intended use not evaluated by FDA.
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
Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
Brand
Stryker, Inc.
Lot Codes / Batch Numbers
UDI: (01)07613327313956/Lot Number(s): 0000136913 0000144331, 0000163582, 0000164440, 0000182275, 0000230955, 0000240597, 0000244845, 0000370674
Products Sold
UDI: (01)07613327313956/Lot Number(s): 0000136913 0000144331, 0000163582, 0000164440, 0000182275, 0000230955, 0000240597, 0000244845, 0000370674
Stryker, Inc. is recalling Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm due to The microcatheter IFU contains an intended use that has not been evaluated by the FDA.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The microcatheter IFU contains an intended use that has not been evaluated by the FDA.
Recommended Action
Per FDA guidance
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 communication internally until all required actions have been completed within your facility. 6. Inform Stryker if any of the subject devices have been distributed to other organizations. If yes, provide contact details so that Stryker can inform the recipients appropriately. 7. Please inform Stryker 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) 8. Complete the attached customer response form. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. 9. Email the completed form to nvfieldactions@stryker.com
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