OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Code information: Lot #'s: C1-08611 Exp. February 20, 2017, C1-09397 Exp. November 17, 2017, C1-09408 Exp. November 25, 2017, C1-09408 Exp. November 25, 2017, C1-09861 Exp. March 5, 2018, C1-09858 Exp. March 5, 2018, C1-09861 Exp. March 5, 2018, C1-10901 Exp. July 19, 2018, C1-11205 Exp. August 24, 2018, C1-11205 Exp. August 24, 2018, C1-12250 Exp. January 4, 2019, C1-08611 Exp. February 20, 2017, and C1-11205 Exp. August 24, 2018

Distribution pattern: Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM