OSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM D66CM Catalog # AB081043 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: C1-08337 Exp. November 7, 2016, OR-4658 Exp. April 20, 2018, C1-08337 Exp. November 7, 2016, and C1-08337 Exp. November 7, 2016

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