Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;

Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Code information: SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); UDI-DI: 25051684007891(Box), 15051684007894(Pouch); Lot No.: A2825033, A2825034, A2825132, A2825133, A3725048, A3725049;

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, Thailand.