Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Synchro .014"guide wire Recalled by Stryker Neurovascular Due to Neurovascular devices did not meet the minimum sample...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Neurovascular directly.
Affected Products
Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Catalog: M00313310 SYNCHRO .010 WIRE SOFT STRAIGHT 200cm, Catalog: M00316310 SYNCHRO .010 WIRE SOFT STRAIGHT 300cm, Catalog: M00316330
Quantity: 2859
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Stryker Neurovascular
Stryker Neurovascular has 108 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report