OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 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: C1-09848 Exp. March 4, 2018, C1-11207 Exp. August 24, 2018, C1-11249 Exp. August 30, 2018, C1-09099 Exp. July 15, 2017, C1-09099 Exp. July 15, 2017, C1-09407 Exp. November 24, 2017, C1-09848 Exp. March 4, 2018, C1-10382 Exp. May 17, 2018, C1-11207 Exp. August 24, 2018, C1-11249 Exp. August 30, 2018, OR-04730 Exp. October 29, 2018, C1-09099 Exp. July 15, 2017, C1-09407 Exp. November 24, 2017 and C1-09848 Exp. March 4, 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