HIGH

Cook Medical Recalls Zenith Alpha 2 Thoracic Endovascular Graft

Cook Medical recalled 695 Zenith Alpha 2 Thoracic Endovascular Grafts on September 18, 2025. The recall follows reports that PTFE coating scrapings could cause intravascular embolization during deployment. Patients and healthcare providers must stop using the device immediately.

Quick Facts at a Glance

Recall Date
September 18, 2025
Hazard Level
HIGH
Brand
Cook Medical
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
Nationwide (50 states)
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cook Medical Incorporated or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recalled devices are identified by Catalog Prefix ZTA2 and Reference Part Numbers including ZTA2-P-40-117-W, ZTA2-P-40-167, and others. They were distributed domestically across 20 states and internationally to countries including Switzerland and Germany.

The Hazard

The devices may contain scrapings from the PTFE coating. These scrapings could be released during deployment, posing a risk of intravascular embolization, which can lead to serious health complications.

What to Do

Patients and healthcare providers should stop using the devices immediately. Contact Cook Medical Incorporated or your healthcare provider for further instructions.

Contact Information

For more information, visit Cook Medical's website or call their customer service line. Additional recall details are available at the FDA's website.

Key Facts

  • Recall date: September 18, 2025
  • Quantity recalled: 695 devices
  • Distributed to 20 U.S. states and several countries
  • Hazard: PTFE coating scrapings could cause embolization
  • Contact Cook Medical for further instructions
View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeThoracic Endovascular Graft
Sold At
Multiple Retailers

Product Details

Model 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
+15 more
Affected States
Nationwide
Report Date
October 22, 2025
Recall Status
ACTIVE

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