OSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM Catalog # AB081041 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: C1-12312 Exp. January 18, 2019, OR-04686 Exp. July 16, 2018, Exp. April 21, 2015, OR-04655 Exp. April 20, 2018, C1-10985 Exp. July 28, 2018, OR-04686 Exp. July 16, 2018, C1-12312 Exp. January 18, 2019, C1-12312 Exp. January 18, 2019, and OR-04655 Exp. April 20, 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