Stryker recalls Trevo ProVue devices (Catalog: 90184) that may have high endotoxin levels, increasing risk of fever, shock, or aseptic meningitis. Affected units include specific lots and UDI-DI numbers.
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 Trevo ProVue devices that may have high endotoxin levels from manufacturing, which could cause fever, shock, or aseptic meningitis. This recall affects specific lots and UDI-DI numbers.
Endotoxins are natural components of bacterial cell walls that can enter the bloodstream during medical procedures. High levels may cause fever, shock, or aseptic meningitis in patients, especially during surgeries involving the nervous system.
Healthcare professionals using these devices for neurovascular procedures are most at risk. Patients receiving these devices during surgery may be affected if they have high endotoxin levels.
Check for the product catalog number 90184. Affected units include specific lots (118117, 118420, 118833) and UDI-DI number 00815742001846.
Look for the catalog number 90184, specific lots (118117, 118420, 118833), and UDI-DI number 00815742001846 on the device packaging.
High endotoxin levels may increase the risk of fever, shock, or aseptic meningitis in patients during surgery.
Check for catalog number 90184, specific lots (118117, 118420, 118833), and UDI-DI number 00815742001846 on the device packaging.
The recall does not specify a stop-use instruction; affected devices should be checked for the specific identifiers to determine if they are recalled.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1903-2024 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1903-2024 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.
