Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Gateway OTW 2.75mm x 9mm Recalled by Stryker Neurovascular Due to Units of GDC 360 coils, Target coil and...
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
Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose of improving intracranial perfusion.
Quantity: 1 unit
Why Was This Recalled?
Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
Where Was This Sold?
This product was distributed to 4 states: NH, OH, TX, VA
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