Z-0021-2025Class II

The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque...

Name: Z-0021-2025 The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque...
Creator: Stryker Neurovascular
Published: 2024-08-30
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2024-08-30 / Open, Classified / root cause: labeling and UDI

FDA source

Stryker Neurovascular began a recall of 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... on 2024-08-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0021-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-30
Posted: 2024-10-07
Recalling firm: Stryker Corp.
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.
Product code: QJP Catheter, Percutaneous, Neurovasculature
Reason for recall: 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 tag: labeling and UDI
FDA 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 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: [email protected]). 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 [email protected]. Contact the local Stryker representative, send an email to [email protected] or call US Customer Service: 1-855-91-NEURO (1-855-916-3876) for further assistance related to this Medical Device Recall Customer Notification.
Quantity in commerce: 6
Distribution: U.S. Nationwide distribution in the states of CA and VA.
Product codes and lots: Model/Catalog Number: 90338 UDI Codes: (01)07613327313956(17)251125(10)0000590444 (01)07613327313956(17)260101(10)0000603275 Lot Numbers: 0000590444 0000603275

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0021-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0021-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-16	2024-10-07

Product code QJP

K211594Class IITrevo Trak 21 MicrocatheterStryker Neurovascular / cleared 2021-11-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)