Stryker recalls specific Trevo Trak 21 Microcatheter models due to unapproved FDA use. Affected units have unique lot numbers; contact Stryker for details.
The microcatheter IFU contains an intended use that has not been evaluated by the FDA.
Stryker is recalling certain Trevo Trak 21 Microcatheters because their instructions for use haven't been evaluated by the FDA. This could pose risks if used without proper regulatory approval.
The microcatheter's instructions for use (IFU) were not reviewed by the FDA, meaning it might not be safe for intended medical procedures. This could lead to complications if used without proper regulatory approval.
Healthcare professionals using the specific microcatheter models with the listed lot numbers are most at risk. Patients receiving these devices during procedures may also be affected.
Check the microcatheter's lot number on the packaging or label. Affected units have specific lot numbers listed in the recall notice: 0000136913, 0000144331, 0000163582, 0000164440, 0000182275, 0000230955, 0000240597, 0000244845, 0000370674.
Look for the lot number on the microcatheter packaging or label to determine if it's affected.
The microcatheter's instructions for use have not been evaluated by the FDA, which could pose risks if used without proper regulatory approval.
Affected lot numbers include 0000136913, 0000144331, 0000163582, 0000164440, 0000182275, 0000230955, 0000240597, 0000244845, and 0000370674.
The recall does not specify a stop-use instruction; check the lot number to see if your product is affected.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1085-2024 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1085-2024 from Stryker. 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.
