Boston Scientific Hurricane RX Dilation Balloons Recalled for Pressure Loss Defect
Boston Scientific is recalling specific lots of Hurricane RX Dilation Balloons due to a pinhole defect that causes pressure loss, resulting in prolonged endoscopic procedures. Affected devices are used for dilating strictures in the bile duct.
- Product
- HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
- Category
- Medical Device
- Distribution
- Distributed nationwide