ENDOVASCULAR PACK; Model/Item Number (Kit): VAPX014-04;

Product may be potentially contaminated with a lubricant used during the manufacturing process.

On August 10, 2026, URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: 1. Identify, segregate, and quarantine all Avid kits identified in Attachment 1. 2. Add recall labels to affected Avid kits to ensure all users are aware of the actions to discard the impacted component. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. Please contact your Sales Representative if pre-printed labels are needed. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. - Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. -Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness.