Reported Oct 22, 2025 · Ongoing

Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167…

Cook Medical Incorporated

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cook Medical Incorporated · 400 N Daniels Way · Bloomington, IN · 47404-9155

Is this the product you have?

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

Lot codes and dates: 36 of 36 products
Products covered by this recall
# Barcodes Product as published
1 1082700259915100827002599154 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
2 1082700259920500827002599208 ZTA2-P-40-167 Box UDI-DI 10827002599205 Product UDI-DI 00827002599208 Lots E4715752 E4718032 E4718033 E4718034 E4718035
3 1082700259921200827002599215 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
4 1082700259923600827002599239 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
5 1082700259925000827002599253 ZTA2-P-42-121 Box UDI-DI 10827002599250 Product UDI-DI 00827002599253 Lot E4718044
6 1082700259926700827002599260 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
7 1082700259931100827002599314 ZTA2-P-42-173 Box UDI-DI 10827002599311 Product UDI-DI 00827002599314 Lots E4715753 E4715754 E4715755 E4721401 E4721402 E4721403
8 1082700259932800827002599321 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
9 1082700259934200827002599345 ZTA2-P-42-225 Box UDI-DI 10827002599342 Product UDI-DI 00827002599345 Lots E4724678 E4724679 E4724680 E4724681
10 1082700259935900827002599352 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
11 1082700259937300827002599376 ZTA2-P-44-125 Box UDI-DI 10827002599373 Product UDI-DI 00827002599376 Lots E4727703 E4727704
12 1082700259938000827002599383 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
13 1082700259943400827002599437 ZTA2-P-44-179 Box UDI-DI 10827002599434 Product UDI-DI 00827002599437 Lots E4727711 E4727712
14 1082700259944100827002599444 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
15 1082700259946500827002599468 ZTA2-P-44-233 Box UDI-DI 10827002599465 Product UDI-DI 00827002599468 Lots E4718047 E4718048 E4718049
16 1082700259947200827002599475 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
17 1082700259949600827002599499 ZTA2-P-46-125 Box UDI-DI 10827002599496 Product UDI-DI 00827002599499 Lots E4715756 E4718052
18 1082700259950200827002599505 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
19 1082700259907600827002599079 ZTA2-P-46-179 Box UDI-DI 10827002599076 Product UDI-DI 00827002599079 Lots E4715757 E4718053 E4718055 E4718056 E4718057
20 1082700259910600827002599109 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
Page 1 of 2
Amount recalled: 695

Where it was sold

Why it was recalled

Stop using this product now

Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Medical device recalls

Other recalls from Cook Medical Incorporated

EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012 May 22, 2024
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN… Apr 13, 2022
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number… Mar 27, 2019
Zilver 518 Biliary Stent 4mm x 20mm Nov 7, 2018
Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft… Aug 16, 2017
Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System Feb 3, 2016

7 in total.

Where it was distributed

All recall categories · Browse the whole archive

#	Barcodes	Product as published
1	`1082700259915100827002599154`	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
2	`1082700259920500827002599208`	ZTA2-P-40-167 Box UDI-DI 10827002599205 Product UDI-DI 00827002599208 Lots E4715752 E4718032 E4718033 E4718034 E4718035
3	`1082700259921200827002599215`	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
4	`1082700259923600827002599239`	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
5	`1082700259925000827002599253`	ZTA2-P-42-121 Box UDI-DI 10827002599250 Product UDI-DI 00827002599253 Lot E4718044
6	`1082700259926700827002599260`	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
7	`1082700259931100827002599314`	ZTA2-P-42-173 Box UDI-DI 10827002599311 Product UDI-DI 00827002599314 Lots E4715753 E4715754 E4715755 E4721401 E4721402 E4721403
8	`1082700259932800827002599321`	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
9	`1082700259934200827002599345`	ZTA2-P-42-225 Box UDI-DI 10827002599342 Product UDI-DI 00827002599345 Lots E4724678 E4724679 E4724680 E4724681
10	`1082700259935900827002599352`	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
11	`1082700259937300827002599376`	ZTA2-P-44-125 Box UDI-DI 10827002599373 Product UDI-DI 00827002599376 Lots E4727703 E4727704
12	`1082700259938000827002599383`	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
13	`1082700259943400827002599437`	ZTA2-P-44-179 Box UDI-DI 10827002599434 Product UDI-DI 00827002599437 Lots E4727711 E4727712
14	`1082700259944100827002599444`	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
15	`1082700259946500827002599468`	ZTA2-P-44-233 Box UDI-DI 10827002599465 Product UDI-DI 00827002599468 Lots E4718047 E4718048 E4718049
16	`1082700259947200827002599475`	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
17	`1082700259949600827002599499`	ZTA2-P-46-125 Box UDI-DI 10827002599496 Product UDI-DI 00827002599499 Lots E4715756 E4718052
18	`1082700259950200827002599505`	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
19	`1082700259907600827002599079`	ZTA2-P-46-179 Box UDI-DI 10827002599076 Product UDI-DI 00827002599079 Lots E4715757 E4718053 E4718055 E4718056 E4718057
20	`1082700259910600827002599109`	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