Recall archive / FDA device enforcement
Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C1... — FDA record Z-0657-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 21, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE; ENBF2313C120EE; ENBF2313C145EE; ENBF2313C170EE; ENBF2316C120EE; ENBF2316C145EE; ENBF2316C170EE; ENBF2513C120EE; ENBF2513C145EE; ENBF2513C170EE; ENBF2516C120EE; ENBF2516C145EE; ENBF2516C170EE; ENBF2813C145EE; ENBF2813C170EE; ENBF2816C120EE; ENBF2816C145EE; ENBF2816C170EE; ENBF3216C120EE; ENBF3216C145EE; ENBF3216C170EE; ENBF3616C145EE; ENBF3616C170EE; ENCF2323C45EE; ENCF2525C45EE; ENCF2828C45EE; ENCF3232C45EE; ENCF3636C45EE; ENTF2323C70EE; ENTF2525C70EE; ENTF2828C70EE; Medtronic Endurant II Stent Graft System Model/REF ETBF2313C124E; ETBF2313C124EE; ETBF2313C145EE; ETBF2313C145EJ; ETBF2313C166EE; ETBF2313C166EJ; ETBF2316C124E; ETBF2316C124EE; ETBF2316C124EJ; ETBF2316C145E; ETBF2316C145EE; ETBF2316C145EJ; ETBF2316C166E; ETBF2316C166EE; ETBF2316C166EJ; ETBF2513C124E; ETBF2513C124EE; ETBF2513C124EJ; ETBF2513C145EE; ETBF2513C145EJ; ETBF2513C166E; ETBF2513C166EE; ETBF2513C166EJ; ETBF2516C124EE; ETBF2516C145E; ETBF2516C145EE; ETBF2516C145EJ; ETBF2516C166E; ETBF2516C166EE; ETBF2516C166EJ; ETBF2813C124EE; ETBF2813C124EJ; ETBF2813C145E; ETBF2813C145EE; ETBF2813C145EJ; ETBF2813C166E; ETBF2813C166EE; ETBF2813C166EJ; ETBF2816C124EE; ETBF2816C124EJ; ETBF2816C145E; ETBF2816C145EE; ETBF2816C145EJ; ETBF2816C166E; ETBF2816C166EE; ETBF2816C166EJ; ETBF2820C124EE; ETBF2820C145EE; ETBF2820C145EJ; ETBF2820C166E; ETBF2820C166EE; ETBF2820C166EJ; ETBF3216C124E; ETBF3216C124EE; ETBF3216C124EJ; ETBF3216C145E; ETBF3216C145EE; ETBF3216C145EJ; ETBF3216C166EE; ETBF3216C166EJ; ETBF3220C124EE; ETBF3220C145EE; ETBF3220C166E; ETBF3220C166EE; ETBF3220C166EJ; ETBF3616C145E; ETBF3616C145EE; ETBF3616C145EJ; ETBF3616C166E; ETBF3616C166EE; ETBF3616C166EJ; ETBF3620C145EE; ETBF3620C166EE; ETBF3620C166EJ; ETCF2323C49E; ETCF2323C49EE; ETCF2525C49E; ETCF2525C49EE; ETCF2525C49EJ; ETCF2828C49E; ETCF2828C49EE; ETCF2828C49EJ; ETCF3232C49E; ETCF3232C49EE; ETCF3232C49EJ; ETCF3636C49E; ETCF3636C49EE; ETCF3636C49EJ; ETTF2323C70E; ETTF2323C70EE; ETTF2323C70EJ; ETTF2525C70E; ETTF2525C70EE; ETTF2525C70EJ; ETTF2828C70E; ETTF2828C70EE; ETTF2828C70EJ; ETTF3232C70E; ETTF3232C70EE; ETTF3232C70EJ; ETTF3636C70E; ETTF3636C70EE; ETTF3636C70EJ; ETUF2314C102E; ETUF2314C102EE; ETUF2314C102EJ; ETUF2514C102E; ETUF2514C102EE; ETUF2514C102EJ; ETUF2814C102E; ETUF2814C102EE; ETUF2814C102EJ; ETUF3214C102E; ETUF3214C102EE; ETUF3614C102E; ETUF3614C102EE; Medtronic Endurant IIs Stent Graft System Model/REF: ESBF2314C103E; ESBF2314C103EE; ESBF2314C103EJ; ESBF2514C103E; ESBF2514C103EE; ESBF2514C103EJ; ESBF2814C103E; ESBF2814C103EE; ESBF2814C103EJ; ESBF3214C103E; ESBF3214C103EE; ESBF3214C103EJ; ESBF3614C103E; ESBF3614C103EE; ESBF3614C103EJ; Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.
- Reason
- Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.
- Classification
- Class II
- Recalling firm
- Medtronic Vascular, Inc.
- Quantity
- 14,629 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0657-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number/GTIN: ENBF2313C120EE/00763000005528 Serial Numbers: V30540648 V30540649 V30540650 ENBF2313C145EE/00763000005535 Serial Numbers: V30528369 V30528370 V30528371 V30528374 V30528375 V30528376 V30528611 V30528612 V30528613 V30528614 V30528615 V30528616 V30528617 V30528618 V30528619 V30544486 V30544487 V30544488 V30544489 V30544491 V30544492 V30544493 V30544494 V30544953 V30544954 V30544955 V30544956 V30544957 V30544958 V30544959 V30544960 V30544961 V30544962 V30579806 V30579807 V30579808 V30579809 V30579810 V30579811 V30579812 V30579813 V30579814 V30579815 V30579816 V30579817 V30579818 V30579819 V30579820 V30579821 V30579822 V30579823 V30579824 V30579825 V30581739 V30581740 V30581741 V30581742 V30581743 V30581744 V30581745 V30581746 V30581747 V30581748 V30581749 V30581750 V30581751 V30581752 V30581753 V30581754 V30581755 V30581756 V30581757 V30581758 V30583356 V30583357 V30583358 V30583359 V30583360 V30603508 V30603509 V30603510 V30603511 V30603512 V30603513 V30603514 V30603515 V30603516 V30603517 V30603518 V30603519 V30603520 V30603521 V30603522 V30603523 V30603524 V30603525 V30603526 V30606497 V30606498 V30606499 V30606500 V30606501 V30606502 V30606503 V30606504 V30606505 V30606506 V30606507 V30606508 V30606509 V30606510 V30606511 V30606512 V30606513 V30606514 V30606515 V30606516 ENBF2313C170EE/00763000005542 Serial Numbers: V30509849 V30509850 V30509851 V30509852 V30543246 V30543247 V30543248 V30543249 V30543250 V30543301 V30543302 V30543303 V30543304 V30543305 V30543306 V30543307 V30543308 V30543309 V30544963 V30544964 V30544965 V30544966 V30544967 V30544968 V30544969 V30544970 V30544971 V30544972 V30544973 V30544974 V30544975 V30544976 V30544977 V30544978 V30544979 V30544980 V30544981 V30544982 V30583361 V30583362 V30583363 V30583364 V30583365 V30583366 V30583367 V30583368 V30583369 V30583370 V30597232 V30597233 V30597234 V30597235 V30597236 V30597237 V30597238 V30597239 V30597240 V30597241 V30597242 V30597243 V30597244 V30597245 V30597246 V30597247 V30597248 V30597249 V30597250 V30597251 V30603528 V30603529 V30603530 V30603531 V30603532 V30603533 V30603534 V30603535 V30603536 V30670374 V30670375 V30670376 V30670377 V30670378 V30670379 V30670380 V30670381 V30670382 V30670383 V30670719 V30670720 V30670721 V30670722 V30670723 V30670724 V30670725 V30670726 ENBF2316C120EE/00763000005559 Serial Numbers: V30529438 V30529439 V30529440 V30529441 V30529442 V30583371 V30583372 V30583373 V30583374 V30583375 ENBF2316C145EE/00763000005566 Serial Numbers: V30509854 V30509855 V30509856 V30509857 V30509858 V30544496 V30544497 V30544498 V30544499 V30544500 V30544501 V30544502 V30544503 V30544504 V30544505 V30544506 V30544507 V30544508 V30544509 V30544510 V30544511 V30544512 V30544513 V30544514 V30544515 V30583376 V30583377 V30583378 V30583379 V30583380 V30583381 V30583382 V30583383 V30583384 V30583385 V30597252 V30597253 V30597254 V30597255 V30597256 V30597257 V30597258 V30597259 V30597260 V30597261 V30597262 V30597263 V30597264 V30597265 V30597266 V30597267 V30597268 V30597269 V30597270 V30597271 V30606517 V30606518 V30606519 V30606520 V30606521 V30606522 V30606523 V30606524 V30606525 V30606526 V30606527 V30606528 V30606529 V30606530 V30606531 V30606532 V30606533 V30606534 V30606535 V30606536 ENBF2316C170EE/00763000005573 Serial Numbers: V30528640 V30528641 V30528642 V30528643 V30528644 V30528645 V30528646 V30528647 V30528648 V30528649 V30529608 V30529609 V30529610 V30529611 V30529612 V30544983 V30544984 V30544985 V30544986 V30544987 V30577699 V30577700 V30577701 V30577702 V30577703 V30577704 V30577705 V30577706 V30577707 V30577708 V30577709 V30577710 V30577711 V30577712 V30577713 V30583386 V30583387 V30583388 V30583389 ENBF2513C120EE/00763000005580 Serial Numbers: V30529613 V30529614 V30529615 V30529616 V30529617 V30583391 V30583392 V30583393 V30583394 V30583395 ENBF2513C145EE/00763000005597 Serial Numbers: V30544516 V30544517 V30544518 V30544519 V30544520 V30544521 V30544522 V30544523 V30544524 V30544525 V30544526 V30544527 V30544528 V30544529 V30544530 V30544531 V30544532 V30544533 V30544534 V30583396 V30583397 V30583398 V30583399 V30583400 V30583401 V30583402 V30583403 V30583404 V30583405 V30583406 V30583407 V30583408 V30583409 V30583410 V30597272 V30597273 V30597274 V30597275 V30597276 V30597277 V30597278 V30597279 V30597280 V30597281 V30597282 V30597283 V30597284 V30597285 V30597286 V30597287 V30597288 V30597289 V30597290 V30597291 V30606537 V30606538 V30606539 V30606540 V30606541 V30606542 V30606543 V30606544 V30606545 ENBF2513C170EE/00763000005603 Serial Numbers: V30541359 V30541360 V30541361 V30541362 V30541363 V30541364 V30541365 V30541366 V30541367 V30541368 V30541369 V30541370 V30541371 V30541372 V30541373 V30541374 V30541375 V30541376 V30541377 V30541378 V30544988 V30544989 V30544990 V30544991 V30544992 V30544993 V30544994 V30544995 V30544996 V30544997 V30544998 V30544999 V30545000 V30545001 V30545002 V30545003 V30545004 V30545005 V30545006 V30545007 V30581789 V30581790 V30581791 V30581792 V30581793 V30581794 V30581795 V30581796 V30581797 V30581798 V30581799 V30581800 V30581801 V30581802 V30581803 V30581804 V30581805 V30581806 V30581807 V30581808 V30581809 V30581810 V30581811 V30581812 V30581813 V30581814 V30581815 V30581816 V30581817 V30581818 V30597292 V30597293 V30597294 V30597295 V30597296 V30597297 V30597298 V30597299 V30597300 V30597301 V30597302 V30597303 V30597304 V30597305 V30597306 V30670424 V30670425 V30670426 V30670427 V30670428 V30670429 V30670430 V30670431 V30670432 V30670433 V30670434 V30670435 V30670436 V30670437 V30670438 V30670439 V30670440 V30670441 V30670442 V30670443 ENBF2516C120EE/00763000005610 Serial Numbers: V30528418 V30528419 V30528420 V30528421 V30528422 V30528423 ENBF2516C145EE/00763000005627 Serial Numbers: V30528675 V30528676 V30528677 V30528678 V30528679 V30528680 V30528681 V30528682 V30528683 V30528684 V30528685 V30528686 V30528687 V30528688 V30528691 V30528692 V30528693 V30528694 V30541379 V30541380 V30541381 V30541382 V30541383 V30541384 V30541385 V30541386 V30541387 V30541388 V30541389 V30541390 V30541391 V30541392 V30541393 V30541394 V30541395 V30541396 V30541397 V30541398 V30543311 V30543312 V30543313 V30543314 V30543315 V30543316 V30543317 V30543318 V30543319 V30543320 V30543321 V30543322 V30543323 V30543324 V30543325 V30543326 V30543327 V30543328 V30543329 V30543330 V30545008 V30545009 V30545010 V30545011 V30545012 V30545013 V30545014 V30545015 V30581819 V30581820 V30581821 V30581822 V30581823 V30581824 V30581825 V30581826 V30581827 V30581828 V30581829 V30581830 V30581831 V30581832 V30581833 V30581834 V30581835 V30581836 V30581837 V30581838 V30581839 V30581840 V30581841 V30581842 V30581843 V30581844 V30581845 V30581846 V30581847 V30581848 V30581849 V30581850 V30581851 V30581852 V30581853 V30581854 V30581855 V30581856 V30581857 V30581858 V30582917 V30582918 V30582919 V30582920 V30582921 V30582922 V30582923 V30582924 V30582925 V30582926 V30582927 V30582928 V30582929 V30582930 V30582931 V30582932 V30582933 V30582934 V30582935 V30582936 V30597307 V30597308 V30597309 V30597310 V30597311 V30597312 V30597313 V30597314 V30597315 V30597316 V30597317 V30597318 V30597319 V30597320 V30597321 V30597322 V30597323 V30597324 V30597325 V30597326 V30597327 V30597328 V30597329 V30597330 V30597331 V30597332 V30597333 V30597334 V30597335 V30597336 V30597337 V30597338 V30597339 V30597340 V30597341 V30597342 V30597343 V30597344 V30597345 V30597346 V30606547 V30606548 V30606549 V30606550 V30606551 V30606552 V30606553 V30606554 V30606555 V30606556 V30606557 V30606558 V30606559 V30606560 V30606561 V30606562 V30606563 V30606564 V30670444 V30670445 V30670446 V30670447 V30670448 V30670449 V30670450 V30670451 V30670452 V30670453 V30670454 V30670455 V30670456 V30670457 V30670458 V30670459 V30670460 V30670461 V30670464 V30670465 V30670466 V30670467 V30670468 V30670469 V30670470 V30670471 V30670472 V30670473 V30670474 V30670475 V30670476 V30670477 V30670478 V30670479 V30670480 V30670481 V30670482 V30670483 ENBF2516C170EE/00763000005634 Serial Numbers: V30511410 V30511411 V30511412 V30511413 V30511414 V30528695 V30528696 V30528697 V30528698 V30528699 V30528700 V30528701 V30528702 V30528703 V30528704 V30541399 V30541400 V30541401 V30541402 V30541403 V30541404 V30541405 V30541406 V30541407 V30541408 V30541409 V30541410 V30541411 V30541412 V30541413 V30541414 V30541415 V30541416 V30541417 V30541418 V30543331 V30543332 V30543333 V30543334 V30543335 V30543336 V30543337 V30543338 V30543339 V30544536 V30544537 V30544538 V30544539 V30544540 V30544541 V30544542 V30544543 V30544544 V30544545 V30544546 V30544547 V30544548 V30544549 V30544550 V30544551 V30544552 V30544553 V30544554 V30544555 V30582937 V30582938 V30582939 V30582940 V30582941 V30582942 V30582943 V30582944 V30582945 V30582946 V30582947 V30582948 V30582949 V30582950 V30582951 V30582952 V30582953 V30582954 V30582955 V30582956 V30598683 V30598684 V30598685 V30598686 V30598687 V30598688 V30598689 V30598690 V30598691 V30598692 V30598693 V30598694 V30598698 V30598699 V30598700 V30598701 V30598702 V30598703 V30598704 V30598705 V30598706 V30598707 V30598708 V30598709 V30598710 V30598711 V30598712 V30598713 V30598714 V30598715 V30598716 V30598717 V30670484 V30670485 V30670486 V30670487 V30670488 V30670489 V30670490 V30670491 V30670492 V30670493 V30670494 V30670495 V30670496 V30670497 V30670498 V30670499 V30670500 V30670501 V30670502 V30670503 ENBF2813C145EE/00763000005658 Serial Numbers: V30528705 V30528706 V30528707 V30528708 V30528709 V30563765 V30563766 V30563767 V30563768 V30563769 V30563770 V30563771 V30563772 V30563773 V30563774 V30563775 V30563776 V30563777 V30563778 V30563779 V30563780 V30563781 V30563782 V30563783 V30563784 V30563785 V30563786 V30563787 V30563788 V30563789 V30623542 V30623543 V30623544 V30623545 V30623546 V30623547 V30623548 V30623549 V30623550 V30623551 V30623552 V30623553 V30623554 V30623555 V30623556 V30623557 V30623558 V30623559 V30623560 V30623561 ENBF2813C170EE/00763000005665 Serial Numbers: V30528710 V30528711 V30528712 V30528713 V30528714 V30528715 V30528716 V30528717 V30528718 V30528719 V30563790 V30563791 V30563792 V30563793 V30563794 V30563795 V30563796 V30563797 V30563798 V30563799 V30563800 V30563801 V30563802 V30563803 V30563804 V30597347 V30597348 V30597351 V30597352 V30597353 V30597354 V30597357 V30597358 V30597359 V30597361 V30597362 V30597363 V30597364 V30597365 V30597366 V30598385 V30598386 V30598387 V30598388 V30598389 ENBF2816C120EE/00763000005672 Serial Numbers: V30563811 V30563812 V30563813 V30563814 ENBF2816C145EE/00763000005689 Serial Numbers: V30528720 V30528721 V30528722 V30528723 V30528724 V30528725 V30528726 V30528727 V30528728 V30528729 V30528730 V30528731 V30528732 V30528733 V30528734 V30528735 V30528736 V30528737 V30528738 V30528739 V30528740 V30528741 V30528742 V30528743 V30528744 V30528745 V30528746 V30528747 V30528748 V30528749 V30528750 V30528751 V30528752 V30528753 V30528754 V30535625 V30535626 V30535627 V30535628 V30535629 V30535630 V30535631 V30535632 V30535633 V30535634 V30597367 V30597368 V30597369 V30597370 V30597371 V30597372 V30597373 V30597374 V30597375 V30597376 V30597377 V30597378 V30597379 V30597380 V30597381 V30597382 V30597383 V30597384 V30597385 V30597386 V30597387 V30597388 V30597389 V30597390 V30597391 V30597392 V30597393 V30597394 V30597395 V30597396 V30597397 V30597398 V30597399 V30597400 V30597401 V30597402 V30597403 V30597404 V30597405 V30597406 V30603538 V30603539 V30603540 V30603541 V30603542 V30603543 V30603544 V30603545 V30603546 V30603547 V30603548 V30603549 V30603550 V30603551 V30603552 V30603553 V30603554 V30603555 V30603556 V30603558 V30603559 V30603560 V30603561 V30603562 V30603563 V30603564 V30603565 V30603566 V30603567 V30603568 V30603569 V30603570 V30603571 V30603572 V30603573 V30603574 V30603575 V30603576 V30603577 ENBF2816C170EE/00763000005696 Serial Numbers: V30597407 V30597408 V30597409 V30597410 V30597411 V30597412 V30597413 V30597414 V30597415 V30597416 V30597417 V30597418 V30597419 V30597420 V30597421 V30597... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS,KY, LA, MA, MD, ME, MI, MN, MOMS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, Australia, Austria, Belgium, Bosnia And Herzegovina, Brazil, Bulgaria, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic Of, Kosovo, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, North Macedonia, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay and Viet Nam.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Mar 2, 2022
- Recall initiation date
- Dec 21, 2021
- Center classification date
- Feb 18, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.