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U.S. Department of Health and Human Services

Class 2 Device Recall Endurant IIs Stent Graft System

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  Class 2 Device Recall Endurant IIs Stent Graft System see related information
Date Initiated by Firm October 15, 2021
Create Date November 24, 2021
Recall Status1 Open3, Classified
Recall Number Z-0292-2022
Recall Event ID 88951
PMA Number P100021 
Product Classification System, endovascular graft, aortic aneurysm treatment - Product Code MIH
Product Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EJ STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2314C103E Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E Stent Graft ESBF2314C103E Endur IIs BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2514C103EE STENT GRAFT ESBF2514C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF231
Code Information Model Number/GTIN Code/Product Description: ESBF2814C103EE 00643169780446 V30609409 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609410 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609411 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609412 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609415 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609417 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609420 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609421 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609423 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EJ 00643169440029 V30616743 STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ 00643169440029 V30616746 STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ 00643169440029 V30616748 STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2314C103E 00643169439993 V30618898 Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E 00643169439993 V30618899 Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E 00643169439993 V30618902 Stent Graft ESBF2314C103E Endur IIs BIF ESBF2814C103EE 00643169780446 V30618963 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618964 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618965 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618966 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618967 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618968 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618969 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618970 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618971 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618972 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618973 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618974 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618975 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618976 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618977 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618978 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618979 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618980 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618982 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618983 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618984 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618988 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618989 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2514C103EE 00763000098858 V30619120 STENT GRAFT ESBF2514C103EE ENDUR IIS BIF ESBF2814C103EE 00763000098865 V30619159 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00763000098865 V30619161 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625915 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625916 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625917 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625918 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625921 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625935 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625936 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625938 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625941 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625942 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625943 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625944 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625945 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625946 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625947 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625948 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625949 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625950 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625951 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625952 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625953 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625954 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625957 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625958 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625961 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625962 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625963 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625985 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628576 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628577 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628578 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628579 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628580 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628581 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628582 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628583 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628584 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628585 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628586 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628587 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628588 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2814C103E 00643169439979 V30628625 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628639 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628643 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628652 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628654 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628655 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628657 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628658 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628659 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30628660 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2314C103EE 00643169780422 V30628737 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628738 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628739 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628740 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628741 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628742 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628743 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628744 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628745 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628746 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628747 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628748 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628750 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628751 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628752 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628753 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30628754 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2814C103E 00643169439979 V30629481 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629492 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629493 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629496 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629501 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629503 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629505 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629516 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2814C103E 00643169439979 V30629517 Stent Graft ESBF2814C103E Endur IIs BIF ESBF2514C103E 00643169439986 V30629529 Stent Graft ESBF2514C103E Endur IIs BIF ESBF2514C103E 00643169439986 V30629530 Stent Graft ESBF2514C103E Endur IIs BIF ESBF2514C103E 00643169439986 V30629531 Stent Graft ESBF2514C103E Endur IIs BIF ESBF2514C103E 00643169439986 V30629532 Stent Graft ESBF2514C103E Endur IIs BIF ESBF2514C103E 00643169439986 V30629539 Stent Graft ESBF2514C103E Endur IIs BIF ESBF2814C103EE 00643169780446 V30629760 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629761 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629762 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629763 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629764 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629765 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629766 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629767 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629768 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629770 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629771 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629772 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30629773 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF Serial Numbers: V30609409 V30609410 V30609411 V30609412 V30609415 V30609417 V30609420 V30609421 V30609423 V30616743 V30616746 V30616748 V30618898 V30618899 V30618902 V30618963 V30618964 V30618965 V30618966 V30618967 V30618968 V30618969 V30618970 V30618971 V30618972 V30618973 V30618974 V30618975 V30618976 V30618977 V30618978 V30618979 V30618980 V30618982 V30618983 V30618984 V30618988 V30618989 V30619120 V30619159 V30619161 V30625915 V30625916 V30625917 V30625918 V30625921 V30625935 V30625936 V30625938 V30625941 V30625942 V30625943 V30625944 V30625945 V30625946 V30625947 V30625948 V30625949 V30625950 V30625951 V30625952 V30625953 V30625954 V30625957 V30625958 V30625961 V30625962 V30625963 V30625985 V30628576 V30628577 V30628578 V30628579 V30628580 V30628581 V30628582 V30628583 V30628584 V30628585 V30628586 V30628587 V30628588 V30628625 V30628639 V30628643 V30628652 V30628654 V30628655 V30628657 V30628658 V30628659 V30628660 V30628737 V30628738 V30628739 V30628740 V30628741 V30628742 V30628743 V30628744 V30628745 V30628746 V30628747 V30628748 V30628750 V30628751 V30628752 V30628753 V30628754 V30629481 V30629492 V30629493 V30629496 V30629501 V30629503 V30629505 V30629516 V30629517 V30629529 V30629530 V30629531 V30629532 V30629539 V30629760 V30629761 V30629762 V30629763 V30629764 V30629765 V30629766 V30629767 V30629768 V30629770 V30629771 V30629772 V30629773
Recalling Firm/
Manufacturer		 Medtronic Vascular, Inc.
3850 Brickway Blvd
Santa Rosa CA 95403-8223
For Additional Information Contact Medtronic Customer Service
888-283-7868
Manufacturer Reason
for Recall		 Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
FDA Determined
Cause 2		 Under Investigation by firm
Action On or about 10/15/2021, the firm initiated a global verbal notification to customers informing them that is the potential for a specific subset of 18Fr Stent Graft Systems to have the potential for the spindle to detach from the spindle hypotube during deployment. On 10/18/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification Letter via UPS 2-day delivery. Customers are instructed to take the following actions: 1) Return all unused affected devices to the Recalling Firm via their sales representative or calling customer service at 1-888-283-7868 or email rs.aorticorders@medtronic.com. 2) Complete the enclosed Customer Confirmation Form and email to rs.cfqfca@medtronic.com. 3) Forward this Recall notice to all those who need to be aware within their organization to include physician implanters (US only). Additionally, if any affected devices have been distributed to other organizations, forward this notice to those entities. For questions or assistance - contact their Field Representative or Customer Service at 888-283-7868 or email rs.recalls@medtronic.com.
Quantity in Commerce 419 devices
Distribution Worldwide distribution - U.S. Nationwide distribution in the states of CA, FL, GA, MN, MO, NC, NJ, NM, NV, NY, PA, SC, TN, TX, VA, and WV. The countries of Austria, Belgium, Bulgaria, China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Jordan, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Qatar, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = MIH and Original Applicant = Medtronic Vascular
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