Device recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac catheter

FDA's record gives the reason for recall as: "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."

FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

FDA's distribution pattern field reads: "Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions."

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.