Class I U.S. Food and Drug Administration

Cook Medical Incorporated Zenith Alpha 2 Thoracic Endovascular Graft recall: Affected devices may contain PTFE coating scrapings. Scrapings

Recall published 1+ years ago

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

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

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

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0043-2026
Published
October 22, 2025
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Cook Medical Incorporated
Product type
Medical devices
Units affected
695
Distribution
Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia
Made in
United States
Lot / code info
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 E463…
UPC codes
10827002599151, 00827002599154, 10827002599205, 00827002599208, 10827002599212, 00827002599215, 10827002599236, 00827002599239, 10827002599250, 00827002599253, 10827002599267, 00827002599260, 10827002599311, 00827002599314, 10827002599328, 00827002599321, 10827002599342, 00827002599345, 10827002599359, 00827002599352

Products covered by this recall

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

Check your product

The notice names 27 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10827002599151
  • 00827002599154
  • 10827002599205
  • 00827002599208
  • 10827002599212
  • 00827002599215
  • 10827002599236
  • 00827002599239
  • 10827002599250
  • 00827002599253
  • 10827002599267
  • 00827002599260
  • 10827002599311
  • 00827002599314
  • 10827002599328
  • 00827002599321
  • 10827002599342
  • 00827002599345
  • 10827002599359
  • 00827002599352

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • E4718044
  • E4724678 E4724679 E4724680 E4724681
  • E4727703 E4727704
  • E4727711 E4727712
  • E4718047 E4718048 E4718049
  • E4631977 E4631978 E4631979 E463

Model or item number

On the rating label, the box or the instruction sheet.

  • UDI-DI 00827002599253 Lot E4718044

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Cook Medical Incorporated — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Cook Medical Incorporated — 400 N Daniels Way, Bloomington, IN, 47404-9155

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Cook Medical Incorporated medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10827002599151, 00827002599154, 10827002599205; lot code E4718044, E4724678 E4724679 E4724680 E4724681, E4727703 E4727704; model number UDI-DI 00827002599253 Lot E4718044. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Which states were affected?

The notice lists Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Louisiana and others.

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