MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Catalog # 990079-070-000 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: C1-08310 Exp. October 29, 2016, C1-08364 Exp. November 21, 2016, C1-08606 Exp. February 20, 2017, C1-08611 Exp. February 20, 2017, C1-08802 Exp. April 3, 2017, C1-08857 Exp. April 22, 2017, C1-09091 Exp. July 10, 2017, C1-09090 Exp. July 10, 2017, C1-09859 Exp. March 5, 2018, C1-09860 Exp. March 5, 2018, C1-09880 Exp. March 11, 2018, C1-09921 Exp. March 16, 2018, C1-10039 Exp. April 5, 2018, C1-10141 Exp. April 22, 2018, C1-10141 Exp. April 22, 2018, C1-10146 Exp. April 23, 2018, C1-10242 Exp. May 4, 2018, C1-10240 Exp. May 4, 2018, C1-10241 Exp. May 4, 2018, C1-11206 Exp. August 24, 2018, C1-11206 Exp. August 24, 2018, C1-11572 Exp. September 25, 2018, C1-11572 Exp. September 25, 2018, C1-11850 Exp. October 16, 2018, and C1-11849 Exp. October 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