FDA Medical Device Recalls (openFDA)
Stryker, Inc.: Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
- Recall number
- Z-1085-2024
- Recalling firm
- Stryker, Inc.
- Product
- Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
- Status
- Open, Classified
- Initiated
- 2023-12-06
- Posted
- 2024-02-14
- Terminated
- not on file
- 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 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
- Quantity
- 63 units
- Distribution
- US Nationwide distribution in the states of AL, FL, GA, HI, IL, MI, NC, NH, OH, PA, TX, VA.
- Lot, serial or model codes
- UDI: (01)07613327313956/Lot Number(s): 0000136913 0000144331, 0000163582, 0000164440, 0000182275, 0000230955, 0000240597, 0000244845, 0000370674
- 510(k) numbers
- ["K211594"]
- PMA numbers
- not on file
- Product code
- QJP
- Firm FEI
- 3012931345
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28