FDA-Device2024-05-22Class I
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac catheter
Boston Scientific Corporation
Hazard
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.
Sold states
Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
Affected count
16797 catheters
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Products
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1638-2024Don't want to check this manually?
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