United StatesThe Zenith Alpha 2 Thoracic Endovascular Graft (catalog prefix ZTA2-, affected reference part numbers and specific lot numbers as listed by Cook Medical) is recalled. The devices may contain PTFE coating scrapings that could be released during device deployment, potentially causing intravascular embolization.
What's being recalled
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…
Recalling firm: Cook Medical Incorporated, Bloomington, IN, United States.
How to identify it
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…
The hazard
Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Domestic distribution to AL AR AZ CA CT DC DE FL GA IL IN LA MA MD MI MN MO NC NJ NY OH OR PA SC TN TX UT VA WA WI WV International distribution to Switzerland, Germany, Italy, Poland, and Sweden
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)