Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Guider Softip XF Recalled by Stryker Neurovascular Due to Firm became aware of potentially defective Guider Guide...
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
Guider Softip XF; GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
Quantity: 1478 devices, all models and lot numbers
Why Was This Recalled?
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Where Was This Sold?
This product was distributed to 3 states: AK, IL, OH
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