Stryker recalls specific Trevo Pro 18 Microcatheters due to unapproved FDA use. Affected units have UDI and lot numbers listed. No remedy details provided in official notice.
The microcatheter IFU contains an intended use that has not been evaluated by the FDA.
Stryker is recalling certain Trevo Pro 18 Microcatheters because their instructions for use haven't been evaluated by the FDA. This means the product could be used in ways that aren't approved for safety.
The microcatheter's instructions for use have not been reviewed by the FDA for safety. This could lead to unintended medical consequences if used outside approved procedures.
Healthcare professionals using the specific model and lot numbers listed in the recall notice. Patients receiving procedures with this catheter are at risk if the unapproved use occurs.
Check for the UDI code (01)00815742002386 and lot numbers 0000228865 or 0000370674 on the product packaging. The product is a Trevo Pro 18 Microcatheter with a 0.021in diameter and 150cm length.
Look for the UDI code (01)00815742002386 and lot numbers 0000228865 or 0000370674 on the product packaging.
The microcatheter's instructions for use have not been evaluated by the FDA for safety.
The official recall notice does not specify any remedy steps.
Check for the UDI code (01)00815742002386 and lot numbers 0000228865 or 0000370674 on the product packaging.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1084-2024 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1084-2024 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.
