Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Expo 5F Selective Angiographic Catheters Recalled by Boston Scientific Corporation Due to An increase in complaints related to an inability...
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
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; cardiac catheter
Quantity: 4715 catheters
Why Was This Recalled?
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Where Was This Sold?
Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
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