Stryker Neurovascular recalls DAC 044 115cm devices (Catalog 90760) due to potential endotoxin levels exceeding safety limits, 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 Neurovascular is recalling DAC 044 115cm devices (Catalog 90760) because they may have unsafe endotoxin levels that could lead to fever, shock, or aseptic meningitis. This recall is important because endotoxins in medical devices can cause serious health issues if they exceed safety standards.
These devices may contain excessive endotoxins due to manufacturing defects that didn't meet endotoxin testing standards. High endotoxin levels can cause fever, shock, or aseptic meningitis in patients during medical procedures.
Healthcare professionals using these neurovascular devices in medical settings are most at risk. Patients receiving these devices may also be affected if endotoxin levels are too high.
Check for the model DAC 044 115cm with Catalog number 90760. The device also has a unique identifier UDI-DI: 07613327313918 and lot number 156628.
Look for the model DAC 044 115cm, Catalog number 90760, UDI-DI: 07613327313918, and lot number 156628.
These devices may have unsafe endotoxin levels due to manufacturing defects that didn't meet the required testing standards for endotoxins, which could lead to fever, shock, or aseptic meningitis.
The recall record does not specify a remedy, so contact Stryker Neurovascular directly for guidance.
The recall states potential risks of fever, shock, or aseptic meningitis, but the remedy is not specified, so the risk level is low.
We’ve drafted a message you can send Stryker Neurovascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1908-2024 — Stryker Neurovascular Stryker Neurovascular Hello, I own a Stryker Neurovascular that is covered by recall Z-1908-2024 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.
