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COMPANY ANNOUNCEMENT

Cook Medical Issues Recall Correction of Zenith Alpha™ Thoracic Endovascular Graft and Removes Specific Sizes from the Market

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Medical Devices
Reason for Announcement:
Recall Reason Description
Due to correction to the Instructions For Use
Company Name:
Cook Medical
Brand Name:
Brand Name(s)
Cook Medical
Product Description:
Product Description
Zenith Alpha™ Thoracic Endovascular Graft ‎products

Company Announcement

On June 22, 2017, Cook Medical initiated a correction to the Instructions For Use (IFU) for the Zenith Alpha™ Thoracic Endovascular Graft. This correction removed the indication for blunt thoracic aortic injury, also known as BTAI or “transection” of the aorta because Cook has received an increase in reports of graft thrombosis and occlusion with these grafts specifically in the treatment of BTAI. Cook also initiated a voluntary recall of Zenith Alpha Thoracic products in sizes of 18-22mm, including the 26-22mm tapered device. These specific sizes are primarily used for BTAI, and are no longer available for purchase.

A full list of affected products is attached. Products can be identified by the part number on the outer label of the package. Products in this recall were distributed globally.

Cook Medical has notified its customers and distributors by Medical Device Correction and Removal letters. All customers and distributors were informed to follow the IFU corrections, quarantine and discontinue use of the recalled sizes, and return that affected product to Cook as soon as possible for credit.

FDA and other regulatory agencies around the world have been notified of this action.

Consumers with questions or concerns should contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235, Monday through Friday, between 7:30 a.m. and 5:00 p.m. Eastern time. 

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Adverse events may also be reported to Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235, Monday through Friday, between 7:30 a.m. and 5:00 p.m. Eastern time or by email at CustomerRelationsNA@CookMedical.com.

Cook Medical – Zenith Alpha Thoracic Endovascular Graft Product List

Reference Part Number Global Product Number
ZTA-D-28-160-W G35381
ZTA-D-30-160-W G35383
ZTA-D-32-160-W G35385
ZTA-D-34-142-W G35391
ZTA-D-34-190-W G35392
ZTA-D-36-142-W G35393
ZTA-D-36-190-W G35394
ZTA-D-38-147-W G35395
ZTA-D-38-197-W G35396
ZTA-D-40-147-W G35397
ZTA-D-40-197-W G35398
ZTA-D-42-152-W G35399
ZTA-D-42-204-W G35400
ZTA-D-44-157-W G35401
ZTA-D-44-211-W G35402
ZTA-D-46-157-W G35403
ZTA-D-46-211-W G35404
ZTA-DE-26-104-W G35511
ZTA-DE-30-108-W G35515
ZTA-DE-34-112-W G35519
ZTA-DE-38-91-W G35523
ZTA-DE-42-146-W G38023
ZTA-DE-42-94-W G36346
ZTA-DE-46-97-W G38027
ZTA-P-24-105-W G35333
ZTA-P-24-127-W G35334
ZTA-P-26-105-W G35335
ZTA-P-28-109-W G35337
ZTA-P-28-155-W G35339
ZTA-P-28-201-W G35340
ZTA-P-30-109-W G35341
ZTA-P-30-155-W G35343
ZTA-P-30-201-W G35344
ZTA-P-32-109-W G35345
ZTA-P-32-155-W G35347
ZTA-P-32-201-W G35348
ZTA-P-34-113-W G35349
ZTA-P-34-161-W G35351
ZTA-P-34-209-W G35352
ZTA-P-36-113-W G35353
ZTA-P-36-161-W G35355
ZTA-P-36-209-W G35356
ZTA-P-38-117-W G35357
ZTA-P-38-167-W G35359
ZTA-P-38-217-W G35360
ZTA-P-40-117-W G35361
ZTA-P-40-167-W G35363
ZTA-P-40-217-W G35364
ZTA-P-42-121-W G35365
ZTA-P-42-173-W G35367
ZTA-P-42-225-W G35368
ZTA-P-44-125-W G35369
ZTA-P-44-179-W G35371
ZTA-P-44-233-W G35372
ZTA-P-46-125-W G35373
ZTA-P-46-179-W G35375
ZTA-P-46-233-W G35376
ZTA-PT-30-26-108-W G38072
ZTA-PT-32-28-178-W G38075
ZTA-PT-32-28-201-W G38171
ZTA-PT-34-30-161-W G38172
ZTA-PT-34-30-209-W G38173
ZTA-PT-36-32-161-W G38178
ZTA-PT-36-32-209-W G38179
ZTA-PT-38-34-167-W G38180
ZTA-PT-38-34-217-W G38190
ZTA-PT-40-36-167-W G38191
ZTA-PT-40-36-217-W G38201
ZTA-PT-42-38-173-W G38203
ZTA-PT-42-38-225-W G38204
ZTA-PT-44-40-179-W G38208
ZTA-PT-44-40-233-W G38216
ZTA-PT-46-42-179-W G38220
ZTA-PT-46-42-233-W G38236
ZTA-P-18-105-W G35327
ZTA-P-20-105-W G35329
ZTA-P-22-105-W G35331
ZTA-PT-22-18-105-W G38041
ZTA-PT-26-22-105-W G38055
ZTA-DE-22-104-W G35506

 

 


Company Contact Information

Consumers:
1-800-457-4500 or 1-812-339-2235
CustomerRelationsNA@Cook Medical.com
Media:
Kacey Martin, Content Specialist, PR and Social Media
1-812-339-2235 ext. 5164
kacey.martin@cookmedical.com