Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile Recalled by Stryker Neurovascular Due to The incorrect DFU was packaged with two lots...
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
GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033471020SR0; Neurology: GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that because of their morphology, their location, or the patients general medical condition are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable.
Quantity: 316 total, both models
Why Was This Recalled?
The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.
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