Stryker recalls Trevo Pro 14 and 18 Microcatheters due to potential endotoxin levels exceeding safety standards, which may cause fever, shock, or meningitis.
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
Stryker is recalling two types of microcatheters because they may have unsafe levels of endotoxins that could lead to fever, shock, or meningitis. This is a serious health risk that requires immediate action to prevent potential complications.
These microcatheters may contain higher-than-safe levels of endotoxins due to manufacturing defects. Endotoxins are bacterial components that can cause fever, shock, and aseptic meningitis if they enter the bloodstream.
Healthcare professionals using these microcatheters for medical procedures are most at risk. Patients receiving these devices during surgery may also be affected.
Check for the catalog numbers 90231 or 90238 on the product packaging. The specific lot numbers listed in the recall notice include 00815742002317, 121050, and others.
Immediately stop using the recalled microcatheters as they may contain unsafe endotoxin levels.
The Trevo Pro 14 Microcatheter (Catalog: 90231) and Trevo Pro 18 Microcatheter (Catalog: 90238) are affected.
High endotoxin levels may cause fever, shock, or aseptic meningitis in patients.
Look for catalog numbers 90231 or 90238 on the packaging, and check the specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1904-2024 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1904-2024 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.