Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter

Reason: 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.

Code information: UDI/DI 08714729187844, Batch Numbers: 60432312, 60448988, 60448989, 60459201, 60464505, 60465484, 60467102, 60467103, 60467104, 60467105, 60467106, 60467107, 60467121, 60469088, 60477210, 60477211, 60477213, 60479437, 60479438, 60481581, 60481582

Distribution pattern: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.