Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-P-40-217-W ZTA2-P-42-121 ZTA2-P-42-121-W ZTA2-P-42-173 ZTA2-P-42-173-W ZTA2-P-42-225 ZTA2-P-42-225-W ZTA2-P-44-125 ZTA2-P-44-125-W ZTA2-P-44-179 ZTA2-P-44-179-W ZTA2-P-44-233 ZTA2-P-44-233-W ZTA2-P-46-125 ZTA2-P-46-125-W ZTA2-P-46-179 ZTA2-P-46-179-W ZTA2-P-46-233-W ZTA2-PT-40-36-167 ZTA2-PT-40-36-167-W ZTA2-PT-40-36-217 ZTA2-PT-40-36-217-W ZTA2-PT-42-38-173 ZTA2-PT-42-38-173-W ZTA2-PT-42-38-225 ZTA2-PT-42-38-225-W ZTA2-PT-44-40-179 ZTA2-PT-44-40-179-W ZTA2-PT-44-40-233-W ZTA2-PT-46-42-179 ZTA2-PT-46-42-179-W ZTA2-PT-46-42-233 ZTA2-PT-46-42-233-W ZTA2-P-46-233 ZTA2-PT-44-40-233 ZTA2-P-40-217 ZTA2-P-40-117 ZTA2-P-40-167-DEMO ZTA2-P-44-152-W ZTA2-P-40-142 ZTA2-P-44-152 ZTA2-P-40-142-W
Class I - DangerousWhat Should You Do?
- Check if you have this product: ZTA2-P-40-117-W Box UDI-DI 10827002599151 Product UDI-DI 00827002599154 Lots E4626917 E4627437 E4627438 E4627439 E4627440 E4629948 E4629949 E4629950 E4629951 E4629952 E4629953 E4629954 E4629955 E4634911 E4634913 E4634915 E4634916 E4634917 E4646219 E4656519 E4656520 E4656521 E4659972 E4659973 E4659974 E4665450 E4679401 E4679406 E4683233 E4683236 E4683237 E4683238 E4684592 E4684593 E4701373 E4701375 E4701376 E4701377 E4701378 E4701379 E4701380 E4701402 E4704235; ZTA2-P-40-167 Box UDI-DI 10827002599205 Product UDI-DI 00827002599208 Lots E4715752 E4718032 E4718033 E4718034 E4718035; ZTA2-P-40-167-W Box UDI-DI 10827002599212 Product UDI-DI 00827002599215 Lots E4627442 E4627443 E4627444 E4627445 E4627446 E4627447 E4627448 E4627449 E4627450 E4627451 E4627452 E4631968 E4631969 E4631970 E4634918 E4634919 E4634920 E4635173 E4635174 E4646220 E4656525 E4656526 E4656527 E4656528 E4656529 E4659975 E4665451 E4665452 E4665453 E4670244 E4670245 E4672425 E4672426 E4672427 E4675854 E4677105 E4679407 E4679408 E4679409 E4679410 E4679411 E4679412 E4679413 E4679414 E4679415 E4683243 E4684597 E4684598 E4684601 E4690174 E4690176 E4690178 E4690180 E4701381 E4701382 E4701383 E4701384 E4701385 E4701386 E4704236; ZTA2-P-40-217-W Box UDI-DI 10827002599236 Product UDI-DI 00827002599239 Lots E4629331 E4629332 E4629335 E4629337 E4629338 E4629339 E4646221 E4662229 E4662230 E4662231 E4665454 E4665455 E4665456 E4670246 E4670247 E4672428 E4672431 E4672432 E4675858 E4683246 E4683247 E4695558 E4704238 E4704239; ZTA2-P-42-121 Box UDI-DI 10827002599250 Product UDI-DI 00827002599253 Lot E4718044; ZTA2-P-42-121-W Box UDI-DI 10827002599267 Product UDI-DI 00827002599260 Lots E4629315 E4629341 E4629342 E4629343 E4629344 E4629345 E4629346 E4629347 E4629348 E4629349 E4634921 E4634922 E4656530 E4656531 E4656532 E4659976 E4659977 E4672433 E4672434 E4672435 E4672436 E4672437 E4672438 E4672439 E4675859 E4677112 E4677114 E4677115 E4677117 E4683249 E4683251 E4684603 E4684604 E4684606 E4693147 E4693148 E4701387 E4701389 E4704240 E4704241 E4707614; ZTA2-P-42-173 Box UDI-DI 10827002599311 Product UDI-DI 00827002599314 Lots E4715753 E4715754 E4715755 E4721401 E4721402 E4721403; ZTA2-P-42-173-W Box UDI-DI 10827002599328 Product UDI-DI 00827002599321 Lots E4628827 E4628828 E4628829 E4628830 E4628831 E4628832 E4628833 E4628834 E4628835 E4628836 E4628837 E4646222 E4646223 E4646224 E4646225 E4646226 E4646227 E4659979 E4659980 E4659981 E4672440 E4672441 E4672442 E4672443 E4675860 E4675861 E4679420 E4683254 E4683255 E4684608 E4684609 E4690182 E4690183 E4690184 E4693150 E4693153 E4701390 E4704242 E4704244 E4710863; ZTA2-P-42-225 Box UDI-DI 10827002599342 Product UDI-DI 00827002599345 Lots E4724678 E4724679 E4724680 E4724681; ZTA2-P-42-225-W Box UDI-DI 10827002599359 Product UDI-DI 00827002599352 Lots E4629956 E4629957 E4629958 E4629959 E4634923 E4635175 E4646228 E4646229 E4646230 E4670248 E4672444 E4675862 E4675863 E4679424 E4690185 E4690186 E4707620; ZTA2-P-44-125 Box UDI-DI 10827002599373 Product UDI-DI 00827002599376 Lots E4727703 E4727704; ZTA2-P-44-125-W Box UDI-DI 10827002599380 Product UDI-DI 00827002599383 Lots E4629960 E4629961 E4629962 E4629963 E4629964 E4629965 E4634924 E4634925 E4634926 E4659982 E4662232 E4662233 E4665458 E4670249 E4670250 E4672445 E4672446 E4675864 E4675865 E4677118 E4677119 E4677120 E4677121 E4679427 E4684610 E4684612 E4701391 E4701392 E4701393 E4701394; ZTA2-P-44-179 Box UDI-DI 10827002599434 Product UDI-DI 00827002599437 Lots E4727711 E4727712; ZTA2-P-44-179-W Box UDI-DI 10827002599441 Product UDI-DI 00827002599444 Lots E4631971 E4631972 E4631973 E4631974 E4631975 E4631976 E4634927 E4634928 E4646231 E4659983 E4662234 E4665459 E4665460 E4672447 E4677122 E4677123 E4677125 E4677126 E4677127 E4684614 E4684616 E4684618 E4701395 E4701396 E4701397 E4701398; ZTA2-P-44-233 Box UDI-DI 10827002599465 Product UDI-DI 00827002599468 Lots E4718047 E4718048 E4718049; ZTA2-P-44-233-W Box UDI-DI 10827002599472 Product UDI-DI 00827002599475 Lots E4631977 E4631978 E4631979 E4631980 E4646232 E4646233 E4646234 E4646235 E4646236 E4659984 E4679429 E4679430 E4683261 E4704248 E4707621; ZTA2-P-46-125 Box UDI-DI 10827002599496 Product UDI-DI 00827002599499 Lots E4715756 E4718052; ZTA2-P-46-125-W Box UDI-DI 10827002599502 Product UDI-DI 00827002599505 Lots E4628838 E4628839 E4628841 E4628842 E4628843 E4628844 E4628845 E4628846 E4628847 E4628848 E4634929 E4634930 E4634931 E4635176 E4635177 E4646237 E4646238 E4656533 E4656534 E4656535 E4659985 E4670251 E4672448 E4672449 E4672450 E4677129 E4683262 E4684619 E4684620 E4684621 E4684624 E4690188 E4690189 E4695559 E4695560 E4695561; ZTA2-P-46-179 Box UDI-DI 10827002599076 Product UDI-DI 00827002599079 Lots E4715757 E4718053 E4718055 E4718056 E4718057; ZTA2-P-46-179-W Box UDI-DI 10827002599106 Product UDI-DI 00827002599109 Lots E4628849 E4628850 E4628851 E4628852 E4628853 E4628854 E4628855 E4628856 E4628857 E4628858 E4628859 E4634932 E4634933 E4646239 E4646240 E4646241 E4646242 E4656536 E4656537 E4659987 E4659988 E4672451 E4672452 E4672453 E4672454 E4672455 E4675868 E4684625 E4684627 E4690194 E4707623 E4707625; ZTA2-P-46-233-W Box UDI-DI 10827002599120 Product UDI-DI 00827002599123 Lots E4629966 E4629967 E4629968 E4634936 E4646243 E4646244 E4646245 E4683269 E4683270 E4683272 E4683273 E4684633 E4684635; ZTA2-PT-40-36-167 Box UDI-DI 10827002600635 Product UDI-DI 00827002600638 Lots E4718064 E4718065; ZTA2-PT-40-36-167-W Box UDI-DI 10827002600642 Product UDI-DI 00827002600645 Lots E4628860 E4628861 E4628862 E4628863 E4628864 E4628865 E4628866 E4628867 E4628868 E4628869 E4628870 E4628871 E4628872 E4631981 E4631982 E4631983 E4631984 E4631985 E4631986 E4646246 E4646247 E4656538 E4659990 E4659991 E4659992 E4662235 E4665461 E4665462 E4665463 E4670252 E4670253 E4670254 E4675871 E4675872 E4677137 E4677138 E4677139 E4679432 E4679433 E4679434 E4679435 E4679436 E4683276 E4683278 E4683279 E4684636 E4690195 E4690196 E4690197 E4690198 E4690200 E4690201 E4693157 E4704249 E4704250 E4704251 E4707626 E4707627 E4707628 E4707629 E4710866; ZTA2-PT-40-36-217 Box UDI-DI 10827002600666 Product UDI-DI 00827002600669 Lots E4721425 E4721427 E4721428; ZTA2-PT-40-36-217-W Box UDI-DI 10827002600673 Product UDI-DI 00827002600676 Lots E4628873 E4628874 E4628875 E4628876 E4628877 E4631987 E4631988 E4631989 E4631990 E4631991 E4631992 E4635194 E4635195 E4635196 E4635197 E4656539 E4656540 E4659993 E4670255 E4672463 E4672464 E4684638 E4690202 E4701399 E4701400 E4701401 E4704252 E4704253 E4704254 E4707631 E4710867 E4712860 E4712861; ZTA2-PT-42-38-173 Box UDI-DI 10827002600697 Product UDI-DI 00827002600690 Lots E4718066 E4721429 E4721432; ZTA2-PT-42-38-173-W Box UDI-DI 10827002600703 Product UDI-DI 00827002600706 Lots E4627453 E4627454 E4627455 E4627456 E4627457 E4627458 E4627459 E4627460 E4634937 E4634938 E4634939 E4634940 E4635198 E4646248 E4646250 E4656541 E4656542 E4656543 E4656544 E4659994 E4665464 E4665465 E4672465 E4672466 E4672467 E4672468 E4672469 E4675875 E4675876 E4675877 E4679439 E4679440 E4679441 E4679442 E4683282 E4683283 E4683284 E4683285 E4684641 E4684642 E4684643 E4704255 E4704256 E4704257 E4704258 E4704259 E4707632 E4710868 E4712862 E4712863 E4712864; ZTA2-PT-42-38-225 Box UDI-DI 10827002600727 Product UDI-DI 00827002600720 Lots E4721435 E4721436 E4721438 E4721439; ZTA2-PT-42-38-225-W Box UDI-DI 10827002600734 Product UDI-DI 00827002600737 Lots E4629969 E4629970 E4629971 E4629972 E4629973 E4635199 E4635200 E4635201 E4646251 E4659995 E4659996 E4672470 E4675878 E4684644 E4684645 E4684646 E4690203 E4690204 E4690205 E4690206 E4707636 E4707637 E4710869 E4710870 E4710871; ZTA2-PT-44-40-179 Box UDI-DI 10827002600758 Product UDI-DI 00827002600751 Lots E4724723 E4724724 E4724725 E4724726; ZTA2-PT-44-40-179-W Box UDI-DI 10827002600765 Product UDI-DI 00827002600768 Lots E4631993 E4631994 E4631995 E4631996 E4631997 E4635202 E4635203 E4635204 E4646252 E4646253 E4662236 E4662237 E4672471 E4672472 E4679443 E4683286 E4684647 E4684648 E4690209 E4690211 E4690212 E4693161 E4693162 E4707638 E4707639 E4707640; ZTA2-PT-44-40-233-W Box UDI-DI 10827002600840 Product UDI-DI 00827002600843 Lots E4631998 E4631999 E4632000 E4635205 E4646254 E4646255 E4646257 E4646258 E4679445; ZTA2-PT-46-42-179 Box UDI-DI 10827002600789 Product UDI-DI 00827002600782 Lots E4721440 E4721441 E4721443 E4721445 E4721446 E4721447 E4721448; ZTA2-PT-46-42-179-W Box UDI-DI 10827002600796 Product UDI-DI 00827002600799 Lots E4629937 E4629938 E4629939 E4629940 E4629941 E4629942 E4629974 E4634941 E4634942 E4634943 E4634944 E4634945 E4646259 E4656545 E4656546 E4659997 E4659998 E4659999 E4665466 E4675879 E4677141 E4677142 E4677143 E4679446 E4683288 E4684650 E4684651 E4690213 E4693164 E4693165 E4693166 E4695567 E4710875 E4710876 E4710877 E4710878 E4710879 E4712865 E4712866 E4712867; ZTA2-PT-46-42-233 Box UDI-DI 10827002600819 Product UDI-DI 00827002600812 Lots E4721450 E4721452 E4721453 E4721454 E4721455 E4721456 E4721457 E4721458; ZTA2-PT-46-42-233-W Box UDI-DI 10827002600826 Product UDI-DI 00827002600829 Lots E4629943 E4629945 E4629947 E4634947 E4646261 E4662238 E4683289 E4683290 E4690214 E4693170 E4693171 E4710880
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Cook Medical Incorporated
- Reason for Recall:
- Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-P-40-217-W ZTA2-P-42-121 ZTA2-P-42-121-W ZTA2-P-42-173 ZTA2-P-42-173-W ZTA2-P-42-225 ZTA2-P-42-225-W ZTA2-P-44-125 ZTA2-P-44-125-W ZTA2-P-44-179 ZTA2-P-44-179-W ZTA2-P-44-233 ZTA2-P-44-233-W ZTA2-P-46-125 ZTA2-P-46-125-W ZTA2-P-46-179 ZTA2-P-46-179-W ZTA2-P-46-233-W ZTA2-PT-40-36-167 ZTA2-PT-40-36-167-W ZTA2-PT-40-36-217 ZTA2-PT-40-36-217-W ZTA2-PT-42-38-173 ZTA2-PT-42-38-173-W ZTA2-PT-42-38-225 ZTA2-PT-42-38-225-W ZTA2-PT-44-40-179 ZTA2-PT-44-40-179-W ZTA2-PT-44-40-233-W ZTA2-PT-46-42-179 ZTA2-PT-46-42-179-W ZTA2-PT-46-42-233 ZTA2-PT-46-42-233-W ZTA2-P-46-233 ZTA2-PT-44-40-233 ZTA2-P-40-217 ZTA2-P-40-117 ZTA2-P-40-167-DEMO ZTA2-P-44-152-W ZTA2-P-40-142 ZTA2-P-44-152 ZTA2-P-40-142-W
Product Codes/Lot Numbers:
ZTA2-P-40-117-W Box UDI-DI 10827002599151 Product UDI-DI 00827002599154 Lots E4626917 E4627437 E4627438 E4627439 E4627440 E4629948 E4629949 E4629950 E4629951 E4629952 E4629953 E4629954 E4629955 E4634911 E4634913 E4634915 E4634916 E4634917 E4646219 E4656519 E4656520 E4656521 E4659972 E4659973 E4659974 E4665450 E4679401 E4679406 E4683233 E4683236 E4683237 E4683238 E4684592 E4684593 E4701373 E4701375 E4701376 E4701377 E4701378 E4701379 E4701380 E4701402 E4704235; ZTA2-P-40-167 Box UDI-DI 10827002599205 Product UDI-DI 00827002599208 Lots E4715752 E4718032 E4718033 E4718034 E4718035; ZTA2-P-40-167-W Box UDI-DI 10827002599212 Product UDI-DI 00827002599215 Lots E4627442 E4627443 E4627444 E4627445 E4627446 E4627447 E4627448 E4627449 E4627450 E4627451 E4627452 E4631968 E4631969 E4631970 E4634918 E4634919 E4634920 E4635173 E4635174 E4646220 E4656525 E4656526 E4656527 E4656528 E4656529 E4659975 E4665451 E4665452 E4665453 E4670244 E4670245 E4672425 E4672426 E4672427 E4675854 E4677105 E4679407 E4679408 E4679409 E4679410 E4679411 E4679412 E4679413 E4679414 E4679415 E4683243 E4684597 E4684598 E4684601 E4690174 E4690176 E4690178 E4690180 E4701381 E4701382 E4701383 E4701384 E4701385 E4701386 E4704236; ZTA2-P-40-217-W Box UDI-DI 10827002599236 Product UDI-DI 00827002599239 Lots E4629331 E4629332 E4629335 E4629337 E4629338 E4629339 E4646221 E4662229 E4662230 E4662231 E4665454 E4665455 E4665456 E4670246 E4670247 E4672428 E4672431 E4672432 E4675858 E4683246 E4683247 E4695558 E4704238 E4704239; ZTA2-P-42-121 Box UDI-DI 10827002599250 Product UDI-DI 00827002599253 Lot E4718044; ZTA2-P-42-121-W Box UDI-DI 10827002599267 Product UDI-DI 00827002599260 Lots E4629315 E4629341 E4629342 E4629343 E4629344 E4629345 E4629346 E4629347 E4629348 E4629349 E4634921 E4634922 E4656530 E4656531 E4656532 E4659976 E4659977 E4672433 E4672434 E4672435 E4672436 E4672437 E4672438 E4672439 E4675859 E4677112 E4677114 E4677115 E4677117 E4683249 E4683251 E4684603 E4684604 E4684606 E4693147 E4693148 E4701387 E4701389 E4704240 E4704241 E4707614; ZTA2-P-42-173 Box UDI-DI 10827002599311 Product UDI-DI 00827002599314 Lots E4715753 E4715754 E4715755 E4721401 E4721402 E4721403; ZTA2-P-42-173-W Box UDI-DI 10827002599328 Product UDI-DI 00827002599321 Lots E4628827 E4628828 E4628829 E4628830 E4628831 E4628832 E4628833 E4628834 E4628835 E4628836 E4628837 E4646222 E4646223 E4646224 E4646225 E4646226 E4646227 E4659979 E4659980 E4659981 E4672440 E4672441 E4672442 E4672443 E4675860 E4675861 E4679420 E4683254 E4683255 E4684608 E4684609 E4690182 E4690183 E4690184 E4693150 E4693153 E4701390 E4704242 E4704244 E4710863; ZTA2-P-42-225 Box UDI-DI 10827002599342 Product UDI-DI 00827002599345 Lots E4724678 E4724679 E4724680 E4724681; ZTA2-P-42-225-W Box UDI-DI 10827002599359 Product UDI-DI 00827002599352 Lots E4629956 E4629957 E4629958 E4629959 E4634923 E4635175 E4646228 E4646229 E4646230 E4670248 E4672444 E4675862 E4675863 E4679424 E4690185 E4690186 E4707620; ZTA2-P-44-125 Box UDI-DI 10827002599373 Product UDI-DI 00827002599376 Lots E4727703 E4727704; ZTA2-P-44-125-W Box UDI-DI 10827002599380 Product UDI-DI 00827002599383 Lots E4629960 E4629961 E4629962 E4629963 E4629964 E4629965 E4634924 E4634925 E4634926 E4659982 E4662232 E4662233 E4665458 E4670249 E4670250 E4672445 E4672446 E4675864 E4675865 E4677118 E4677119 E4677120 E4677121 E4679427 E4684610 E4684612 E4701391 E4701392 E4701393 E4701394; ZTA2-P-44-179 Box UDI-DI 10827002599434 Product UDI-DI 00827002599437 Lots E4727711 E4727712; ZTA2-P-44-179-W Box UDI-DI 10827002599441 Product UDI-DI 00827002599444 Lots E4631971 E4631972 E4631973 E4631974 E4631975 E4631976 E4634927 E4634928 E4646231 E4659983 E4662234 E4665459 E4665460 E4672447 E4677122 E4677123 E4677125 E4677126 E4677127 E4684614 E4684616 E4684618 E4701395 E4701396 E4701397 E4701398; ZTA2-P-44-233 Box UDI-DI 10827002599465 Product UDI-DI 00827002599468 Lots E4718047 E4718048 E4718049; ZTA2-P-44-233-W Box UDI-DI 10827002599472 Product UDI-DI 00827002599475 Lots E4631977 E4631978 E4631979 E4631980 E4646232 E4646233 E4646234 E4646235 E4646236 E4659984 E4679429 E4679430 E4683261 E4704248 E4707621; ZTA2-P-46-125 Box UDI-DI 10827002599496 Product UDI-DI 00827002599499 Lots E4715756 E4718052; ZTA2-P-46-125-W Box UDI-DI 10827002599502 Product UDI-DI 00827002599505 Lots E4628838 E4628839 E4628841 E4628842 E4628843 E4628844 E4628845 E4628846 E4628847 E4628848 E4634929 E4634930 E4634931 E4635176 E4635177 E4646237 E4646238 E4656533 E4656534 E4656535 E4659985 E4670251 E4672448 E4672449 E4672450 E4677129 E4683262 E4684619 E4684620 E4684621 E4684624 E4690188 E4690189 E4695559 E4695560 E4695561; ZTA2-P-46-179 Box UDI-DI 10827002599076 Product UDI-DI 00827002599079 Lots E4715757 E4718053 E4718055 E4718056 E4718057; ZTA2-P-46-179-W Box UDI-DI 10827002599106 Product UDI-DI 00827002599109 Lots E4628849 E4628850 E4628851 E4628852 E4628853 E4628854 E4628855 E4628856 E4628857 E4628858 E4628859 E4634932 E4634933 E4646239 E4646240 E4646241 E4646242 E4656536 E4656537 E4659987 E4659988 E4672451 E4672452 E4672453 E4672454 E4672455 E4675868 E4684625 E4684627 E4690194 E4707623 E4707625; 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Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0043-2026
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IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events