Stry: Trevo Trak 21 Microcatheter Recall - OUS IFU Distribution Error
Stryker Neurovascular recalls Trevo Trak 21 Microcatheters with Out of US approved instructions distributed in the US. No immediate action needed as the error is a distribution mistake, not a safety issue.
Lower-risk 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.
Contact the company
What happened, in plain English
Stryker Neurovascular is recalling Trevo Trak 21 Microcatheters that were mistakenly distributed in the US with instructions approved outside the country. This is a distribution error, not a safety hazard, so no action is required. Read more at govinfonow.com/recall/54142-stry-trevo-trak-21-microcatheter-recall-ous-ifu-distribution-error.
Source Summary by GovInfoNow · govinfonow.com/recall/54142-stry-trevo-trak-21-microcatheter-recall-ous-ifu-distribution-error · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0021-2025
Cite this page
“Stry: Trevo Trak 21 Microcatheter Recall - OUS IFU Distribution Error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54142-stry-trevo-trak-21-microcatheter-recall-ous-ifu-distribution-error. Based on FDA recall #Z-0021-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0021-2025%22&limit=1).
Why it’s dangerous
The recall involves microcatheters distributed in the US with instructions approved outside the country. This is a distribution error, not a safety hazard. The error does not affect the product's safety or function.
Who’s affected
Healthcare professionals using the Trevo Trak 21 Microcatheter in medical procedures may own this product. The risk is minimal as it's a distribution error, not a safety issue.
How to tell if you have this one
Check for the model number 90338 on the product label. The lot numbers 0000590444 and 0000603275 are associated with this recall.
- Brand
Stryker Neurovascular- Product
The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s)- Category
Medical device
What to do — step by step
Check Product Label
Look for the model number 90338 and lot numbers 0000590444 or 0000603275 on the product.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
FDA distribution: “U.S. Nationwide distribution in the states of CA and VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Virginia.
Recall timeline
FDA published this recall 47 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0021-2025 (August 30, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0021-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.