Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
Reason for recall: Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System. Distribution: Worldwide distribution: U.S.(nationwide): 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, VT, WA, WI, and WV; and O.U.S.(foreign) to countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Island, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Repub Quantity: 2,240 kits Lot/code info: HeartMate II LVAS Model Numbers: 1. 103393 (cannot be implanted without a LVAD) 2. 106015 (US) 3. 106016 (OUS) Update (February 14, 2024) HeartMate II LVAS: 1. 102139 (OUS), includes Unsealed Outflow Graft with Bend Relief 2. 1355 (US), includes Unsealed Outflow Graft with Bend Relief 3. 103695 (US), includes Unsealed Outflow Graft with Bend Relief 4. 103693 (OUS), includes Unsealed Outflow Graft with Bend Relief 5. 104911 (US) 6. 104912 (OUS) 7. 107801 (US), does not include Outflow Graft 8. 103695-CAN, includes Unsealed Outflow Graft with Bend Relief 9. 104911JPN 10. 106515OUS UDI-DI codes: HeartMate II LVAS: 1. 00813024010807 2. 00813024011224 3. 00813024011231 Update (February 14, 2024) HeartMate II LVAS: 1. N/A 2. 00813024010005 3. 00813024010616 4. 00813024010623 5. 00813024011170 6. 00813024010821 7. 00813024011996 8. N/A 9. 00813024011682 10. 00813024011682 Serial Numbers: US VAD-0357 VAD-0638 VAD-10113 VAD-10162 VAD-10198 VAD-10418 VAD-10543 VAD-10634 VAD-10708 VAD-10734 VAD-10749 VAD-10808 VAD-10840 VAD-10995 VAD-11099 VAD-11104 VAD-11131 VAD-11134 VAD-11241 VAD-11250 VAD-11343 VAD-11369 VAD-11488 VAD-11545 VAD-11602 VAD-11866 VAD-11937 VAD-12055 VAD-12075 VAD-12169 VAD-12174 VAD-12280 VAD-12333 VAD-12344 VAD-12440 VAD-12449 VAD-12454 VAD-12516 VAD-12622 VAD-12641 VAD-12644 VAD-12690 VAD-12756 VAD-12806 VAD-12909 VAD-12943 VAD-13002 VAD-13011 VAD-13094 VAD-13096 VAD-13148 VAD-13161 VAD-13171 VAD-13232 VAD-13263 VAD-13304 VAD-13385 VAD-13388 VAD-13416 VAD-13464 VAD-1
00813024010807, 00813024011224, 00813024011231, 00813024010005, 00813024010616, 00813024010623, 00813024011170, 00813024010821, 00813024011996, 00813024011682
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.