Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures Recalled by Boston Scientific Corporation Due to Balloon pinhole results in losss pressure or fails...
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
HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
Why Was This Recalled?
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
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