BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems.

Due to an increase rate of balloon pinhole defects.

On 04/30/2026, an "URGENT MEDICAL DEVICE RECALL" Letter was mailed to customers informing them that due to an increased rate of balloon pinhole defects (inflation-related issues). Customers are instructed to: 1. Immediately stop using and quarantine the affected BOBBY Balloon Guide Catheters 2. Reconcile, complete and return the "CUSTOMER ACKNOWLEDGEMENT FORM" via email to [email protected] or FAX +1 877-650-7688 and return affected products. 3. Provide Recall Letter to any/all medical facilities to your organization has distributed recalled products to. 4. Return Product -Return product through provided Ground Return Service or Return Service Label receipt provided in this recall notification and ship the products to Processing Center through the below contact. Ship to Address 2670 Executive Drive Suite A Indianapolis, IN 46241 USA -Credit will be issued for customer purchased products upon return and verification of recall unit(s). For Questions or further assistance - contact Sedgwick at +1 877-650-7686 or direct any questions to Terumo Neuro Sr. Director of Post Market Surveillance at +1 949-899-7194 Monday -Friday 8:00 a.m. to 5:00 p.m. (PST) or email [email protected]