OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 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: C1-12572 Exp. June 17, 2019, C1-10896 Exp. July 16, 2018, C1-10896 Exp. July 16, 2018, C1-12139 Exp. November 24, 2018, C1-12572 Exp. June 17, 2019, C1-09133 Exp. August 3, 2017, C1-09133 Exp. August 3, 2017, C1-09943 Exp. March 19, 2018, OR-04641 Exp. March 26, 2018, and C1-10896 Exp. July 16, 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