Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 11012L B. CANNULA 11014L AR FLOWGUARD 14FR LONG, model no. 11014L 3. DLP Aortic Root Cannula with Vent Line A. CANNULA 21012 AR VENT FLOW 12GA, model no. 21012 B. CANNULA 21014 AR VENT FLOW 14GA, model no. 21014

Recall details

Manufacturer

Medtronic Perfusion Systems

Distributor

Domestic distribution nationwide. International distribution to the following countries: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bosnia And Herzegovina Botswana Brazil Bulgaria Canada Canary Islands Cayman Islands Chile China Colombia Costa Rica Croatia Cyprus Czech Republic Denmark Ecuador Egypt Estonia Finland France Georgia Germany Greece Guatemala Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kuwait Latvia Lebanon Lithuania Luxembourg Malaysia Moldova, Republic Of Montenegro Morocco Namibia Nepal Netherlands New Zealand North Macedonia NorthernIreland Norway Oman Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Qatar Reunion Romania Russia Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa South Korea Spain Suriname Sweden Switzerland Taiwan Thailand Turkey Ukraine United Arab Emirates United Kingdom Viet Nam Yemen

Lot

1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 i. UDI-DI 00613994495457, lots 2022050698 2022070054 2023040161 2024040471 2024040475 2024051027 2024051028 ii. UDI-DI 00673978175959, lots 2022050698 2022060347 2022061333 2022081070 2023020720 2023030372 2023031531 2023100234 2023100235 2023120484 2024030256 2024040475 iii. UDI-DI 20613994495451, lots 2022020438 2022030157 2022030297 2022030478 2022030747 2022040309 2022040902 2022050053 2022050697 2022050698 2022060347 2022061333 2022070054 2022070055 2022081070 2022081428 202209C071 202211C054 2023020719 2023020720 2023030372 2023031531 2023040161 2023040433 2023040806 2023041172 2023050066 202305C067 202307C101 2023100087 2023100234 2023100235 2023100489 2023100490 2023100876 2023111145 2023111146 2023120073 2023120484 2023120485 202312C018 2024011341 2024011342 2024011344 202401C303 202401C304 2024020238 202402C163 2024030255 2024030256 2024030692 2024040471 2024040472 2024040473 2024040474 2024040475 2024040476 2024040575 2024051027 2024051028 2024051029 202406C113 202406C114 202407C087 2024100440 2024100441 ***ADDED 6/27/25*** SN 0230896975 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 i. UDI-DI 00613994495488, lots 2022070410 2023041174 2023080113 2023080118 2024040576 ii. UDI-DI 00673978175997, lots 2022050367 2022050702 2022060276 2022070411 2022071072 2022110378 2022110379 2023020394 2023040163 2023050068 2023051166 2023080118 2023080721 2024010419 2024010566 2024030694 2024030965 ***ADDED 6/27/25*** 2024100026 2024100027 UDI-DI 20613994495482, lots 2022010949 2022020094 2022020439 2022020440 2022031296 2022050367 2022050702 2022060276 202206C093 2022070409 2022070410 2022070411 2022070840 2022070841 2022071072 202207C093 2022080418 2022080815 2022081073 202209C066 2022110377 2022110378 2022110379 202301C158 202301C159 2023020394 2023040163 2023040435 2023040809 2023041174 2023041175 2023050068 2023050394 2023050395 2023050396 2023050790 2023051166 2023051167 202305C077 2023060413 2023060414 2023060416 2023060417 2023061123 2023061124 2023061125 2023061126 2023061327 202306C142 202306C143 202307C098 202307C099 2023080113 2023080115 2023080116 2023080118 2023080720 2023080721 2023080722 202308C215 2023111148 2024010350 2024010351 2024010419 2024010566 2024010907 2024010908 202402C164 2024030495 2024030496 2024030693 2024030694 2024030695 2024030696 2024030964 2024030965 2024040576 2024040577 2024040807 2024050923 2024050924 202405C078 202405C088 2024060413 2024060414 2024060415 202407C089 202407C090 202409C108 ***ADDED 6/27/25*** 2024100026 2024100027 0230454264 0230848410 0230848424 0230848506 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 11012L i. UDI-DI 00613994495464, lots 2022010947 2022020079 2022030989 2022031294 2022040308 2022060274 2022070052 2022090112 2022090113 2022090114 2023021126 2023070455 2023070457 2023070466 2023070954 2023070957 2023070959 2023070962 2023111071 2023111072 2023111074 2023111279 2023111280 2023111646 2023111649 2023111650 2024030978 2024030980 2024040009 2024040042 ii. UDI-DI 20613994495468, lots 2022010947 2022010947 2022020079 2022020081 2022020084 2022030745 2022030989 2022031294 2022040135 2022040136 2022040308 2022060274 2022070048 2022070049 2022070050 2022070051 2022070052 2022070053 2022080060 2022080414 2022090111 2022090112 2022090113 2022090114 2022090828 202209C072 202209C083 202211C036 2023021125 2023021126 2023021127 2023021128 2023021129 202304C091 2023070452 2023070455 2023070456 2023070457 2023070458 2023070461 2023070466 2023070954 2023070955 2023070956 2023070957 2023070958 2023070959 2023070960 2023070961 2023070962 2023070963 202308C216 202308C217 202310C187 2023110161 2023111071 2023111072 2023111073 2023111074 2023111075 2023111279 2023111280 2023111644 2023111645 2023111646 2023111647 2023111648 2023111649 2023111650 202312C209 202401C030 202401C031 2024030801 2024030803 2024030978 2024030979 2024030980 2024040008 2024040009 2024040029 20240400

Risk classification

Class I

Area (FDA)

device

Country

United States