Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050

Reason: Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an extended procedure or surgical time while the backup coring knife is acquired.

Code information: REF/UDI-DI/Serial Numbers: 106524US/00813024013297/MLP-034137 to MLP-034744, MLP-035485 to MLP-035714, MLP-036330 to MLP-037708, MLP-038104 to MLP-038999, MLP-039000 to MLP-039999, MLP-040000 to MLP-040999, MLP-041000 to MLP-041621; 106524INT/00813024011712 (OUS)/MLP-032482, MLP-035542 to MLP-035667, MLP-037218 to MLP-037527, MLP-038008 to MLP-038989, MLP-039014 to MLP-039945, MLP-040009 to MLP-040896, MLP-041013 to MLP-041589; 1050/00813024010227: 135021-135025, 134241-134246, 134248, 134250, 134251, 134240, 135060, 135061, 135062, 134247, 132849-132853, 134239; Apical Coring Knife Distributed Separately Serial Number Range: 132849 to 135062

Distribution pattern: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia , Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom.