Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: Recalled by Boston Scientific Corporation Due to Reported Outer sheath distal black tip detaching from...
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 Boston Scientific Corporation directly.
Affected Products
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530
Quantity: 91 units (OUS)
Why Was This Recalled?
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report