Medtronic Perfusion Systems Recall 96259
Description: 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
Medtronic Perfusion Systems Recall 96259 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1306-2025 |
| Event ID | 96259 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | 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 |
| Quantity | 316,205 |
| Recall Reason | Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible). |
| Device Classification | 20250319 |
| Device Code Info | 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 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 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 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 2024040040 2024040041 2024040042 2024040043 2024040044 2024050060 202405C075 202405C076 202406C128 2024070439 2024070499 B. CANNULA 11014L AR FLOWGUARD 14FR LONG, model no. 11014L i. UDI-DI 00613994495495 2022010948 2022010948 2022020088 2022031295 2022040310 2022050699 2022050700 2022060275 2022070056 2022070408 2022080416 2022080417 2022081072 2022100743 2022100744 2022110714 2022110716 2023020724 2023021131 2023040162 2023050067 2023050392 2023060113 2023101328 2023101329 2023101351 2023110294 2023110302 2023110318 2023110553 2023110554 2023110555 2023110556 2023111651 2023111652 2023111654 2023111655 2023111656 2023120163 2023120165 2023121023 2024020443 2024020449 2024020450 2024020451 2024020452 2024020799 2024030344 2024030345 2024030346 2024030805 2024030807 2024030981 2024050387 2024050392 ii. UDI-DI 20613994495499, lots 2022010948 2022010948 2022020086 2022020088 2022020091 2022030298 2022030479 2022030748 2022030990 2022031295 2022040310 2022050699 2022050700 2022050701 2022060275 2022061047 2022061048 2022070056 2022070408 202207C105 202207C106 2022080061 2022080415 2022080416 2022080417 2022081071 2022081072 202209C075 2022100740 2022100741 2022100742 2022100743 2022100744 2022100745 2022110052 2022110054 2022110055 2022110057 2022110714 2022110715 2022110716 202211C037 202301C133 202301C164 2023020721 2023020722 2023020723 2023020724 2023021130 2023021131 2023021132 2023030373 2023030374 2023031532 202303C270 202303C272 2023040162 2023040434 2023040807 2023040808 2023041173 2023050067 2023050391 2023050392 2023050393 2023050788 2023051165 202305C076 2023060113 2023060115 2023060116 2023060119 2023060120 2023060233 2023061326 202306C138 202306C140 202307C100 2023101327 2023101328 2023101329 2023101351 2023110217 2023110253 2023110294 2023110302 2023110318 2023110553 2023110554 2023110555 2023110556 2023110557 2023110558 2023110559 2023110560 2023111069 2023111070 2023111651 2023111652 2023111653 2023111654 2023111655 2023111656 2023120163 2023120165 2023121023 202312C210 202312C211 202312C212 202401C028 202401C029 2024020443 2024020444 2024020445 2024020446 2024020447 2024020448 2024020449 2024020450 2024020451 2024020452 2024020799 2024030344 2024030345 2024030346 2024030805 2024030807 2024030981 2024030982 202403C067 202403C068 2024050386 2024050387 2024050388 2024050389 2024050390 2024050391 2024050392 202405C077 202406C112 2024070502 2024070503 2024070504 2024070746 2024070747 202407C088 2024100986 3. DLP Aortic Root Cannula with Vent Line A. CANNULA 21012 AR VENT FLOW 12GA, model no. 21012 i. UDI-DI 00613994495396, lots 2022050019 2022051040 2022060761 2022060762 2022060763 2022061357 2023040471 2023100246 2023100896 2023120095 2024030275 2024040486 2024070226 2024070519 2024080930 ii. UDI-DI 00673978178325, lots 2022030796 2022040355 2022050019 2022060388 2022060389 2023020765 2023030170 2023031556 2023040199 2023040471 2023040851 2023100245 2023100897 2023111164 2023120097 2024011374 2024011378 2024030276 2024030502 2024040597 2024051034 2024051035 2024051287 iii. UDI-DI 20613994495390, lots 2022011031 2022020476 2022020860 2022030187 2022030188 2022030342 2022030509 2022030796 2022040355 2022040942 2022050019 2022050095 2022050399 2022051040 2022051041 2022060388 2022060389 2022060761 2022060762 2022060763 2022060764 2022061357 2022061358 202206C139 202207C140 2022080099 2022080100 2022081112 2022081113 2022081450 2022081451 2022081452 202209C146 202209C149 202301C214 2023020764 2023020765 2023021173 2023021174 2023030170 2023030171 2023030407 2023030971 2023031039 2023031040 2023031041 2023031555 2023031556 2023031557 2023040199 2023040200 2023040201 2023040470 2023040471 2023040851 2023041219 2023041220 202304C103 2023050113 2023050114 202305C119 202305C120 202305C121 202306C184 2023070519 2023100245 2023100246 2023100511 2023100512 2023100896 2023100897 2023110464 2023110465 2023110467 2023110944 2023111164 2023111165 2023120093 2023120094 2023120095 2023120096 2023120097 2023120505 202312C034 202312C035 2024011374 2024011375 2024011377 2024011378 202401C104 202401C136 2024020259 2024020260 2024030275 2024030276 2024030277 2024030278 2024030279 2024030502 2024030503 2024030504 202403C129 202403C130 2024040485 2024040486 2024040596 2024040597 2024051034 2024051035 2024051036 2024051284 2024051285 2024051286 2024051287 202405C115 202405C116 2024060539 2024070226 2024070519 2024080125 2024080390 2024080929 2024080930 202408C046 202408C047 202410C025 202410C026 B. CANNULA 21014 AR VENT FLOW 14GA, model no. 21014 i. UDI-DI 00613994495402, lots 2022011174 2022020861 2022030973 2022050026 2022061076 2022061078 2022061079 202206C140 2022070457 2022070458 2022070913 2022080456 2022080952 2022110406 2022110426 2023040202 2023041222 2023041223 2023050115 2023050436 2023050861 2023060162 2023060466 2023061168 2023061392 2023080190 2023080723 2024010933 2024060291 2024090936 ii. UDI-DI 00673978178356, lots 2022011033 2022011174 2022020477 2022020861 2022020862 2022030343 2022040356 2022040943 2022050026 2022060390 2022061078 2022070912 2022110406 2022110426 2023020364 2023020423 2023020425 2023031042 2023040202 2023040472 2023040852 2023040853 2023041221 2023080190 2024010335 2024010435 2024010932 2024010933 2024010998 2024051288 2024060293 2024090331 2024090658 iii. UDI-DI 20613994495406, lots 2022011033 2022011174 2022020477 2022020861 2022020862 2022030343 2022030973 2022031019 2022031322 2022040356 2022040943 2022050026 2022050096 2022050400 2022051042 202205C067 2022060390 2022061076 2022061078 2022061079 202206C140 2022070457 2022070458 2022070912 2022070913 2022071098 202207C141 2022080101 2022080102 2022080456 2022080952 202209C168 202209C171 2022110406 2022110425 2022110426 202301C208 202301C209 2023020364 2023020423 2023020424 2023020425 2023031042 2023040202 2023040472 2023040852 2023040853 2023041221 2023041222 2023041223 2023050115 2023050116 2023050435 2023050436 2023050861 2023050862 2023050864 2023050865 202305C122 2023060162 2023060163 2023060465 2023060466 2023061168 2023061169 2023061390 2023061391 2023061392 2023061393 202306C185 202306C186 202306C187 202307C133 202307C135 2023080188 2023080190 2023080723 202309C018 2023111166 2023111167 2024010335 2024010336 2024010435 2024010436 2024010578 2024010579 2024010931 2024010932 2024010933 2024010998 202403C131 202403C132 2024040598 2024040823 2024040824 2024040825 2024050940 2024050941 2024050942 2024050943 2024051288 2024060291 2024060292 2024060293 2024060541 202406C117 202406C118 2024070994 202408C048 202408C049 2024090331 2024090658 2024090936 2024100069 2024100071 |
| Center Classification Date | 20250313 |
| Recall Initiation Date | 20250205 |
| Recalling Firm | Medtronic Perfusion Systems |
| Initial Notification | Letter |
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