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.
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.
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.
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.
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.
Check for the model number 90338 on the product label. The lot numbers 0000590444 and 0000603275 are associated with this recall.
Look for the model number 90338 and lot numbers 0000590444 or 0000603275 on the product.
No, this is a distribution error with no safety hazard. The product is safe to use.
No action is needed as this is a distribution error, not a safety issue.
No action is required. The product is safe to use.
We’ve drafted a message you can send Stryker Neurovascular to request your refund or repair — edit it as you like.
Subject: Recall Z-0021-2025 — Stryker Neurovascular Stryker Neurovascular Hello, I own a Stryker Neurovascular that is covered by recall Z-0021-2025 from Stryker Neurovascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
