Safety

Company Announcement

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.

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

For Immediate Release

August 24, 2017

Contact

Consumers

CustomerRelationsNA@Cook
Medical.com

1-800-457-4500 or
1-812-339-2235

Media

Kacey Martin, Content Specialist,
PR and Social Media
kacey.martin@cookmedical.com
1-812-339-2235 ext. 5164

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. 

Any 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 at www.fda.gov/medwatch/report.htm or via regular mail or fax. Download the form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, and then complete and return to the address on the preaddressed form, or submit by fax to 1-800-FDA-0178.

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 NumberGlobal Product Number
ZTA-D-28-160-WG35381
ZTA-D-30-160-WG35383
ZTA-D-32-160-WG35385
ZTA-D-34-142-WG35391
ZTA-D-34-190-WG35392
ZTA-D-36-142-WG35393
ZTA-D-36-190-WG35394
ZTA-D-38-147-WG35395
ZTA-D-38-197-WG35396
ZTA-D-40-147-WG35397
ZTA-D-40-197-WG35398
ZTA-D-42-152-WG35399
ZTA-D-42-204-WG35400
ZTA-D-44-157-WG35401
ZTA-D-44-211-WG35402
ZTA-D-46-157-WG35403
ZTA-D-46-211-WG35404
ZTA-DE-26-104-WG35511
ZTA-DE-30-108-WG35515
ZTA-DE-34-112-WG35519
ZTA-DE-38-91-WG35523
ZTA-DE-42-146-WG38023
ZTA-DE-42-94-WG36346
ZTA-DE-46-97-WG38027
ZTA-P-24-105-WG35333
ZTA-P-24-127-WG35334
ZTA-P-26-105-WG35335
ZTA-P-28-109-WG35337
ZTA-P-28-155-WG35339
ZTA-P-28-201-WG35340
ZTA-P-30-109-WG35341
ZTA-P-30-155-WG35343
ZTA-P-30-201-WG35344
ZTA-P-32-109-WG35345
ZTA-P-32-155-WG35347
ZTA-P-32-201-WG35348
ZTA-P-34-113-WG35349
ZTA-P-34-161-WG35351
ZTA-P-34-209-WG35352
ZTA-P-36-113-WG35353
ZTA-P-36-161-WG35355
ZTA-P-36-209-WG35356
ZTA-P-38-117-WG35357
ZTA-P-38-167-WG35359
ZTA-P-38-217-WG35360
ZTA-P-40-117-WG35361
ZTA-P-40-167-WG35363
ZTA-P-40-217-WG35364
ZTA-P-42-121-WG35365
ZTA-P-42-173-WG35367
ZTA-P-42-225-WG35368
ZTA-P-44-125-WG35369
ZTA-P-44-179-WG35371
ZTA-P-44-233-WG35372
ZTA-P-46-125-WG35373
ZTA-P-46-179-WG35375
ZTA-P-46-233-WG35376
ZTA-PT-30-26-108-WG38072
ZTA-PT-32-28-178-WG38075
ZTA-PT-32-28-201-WG38171
ZTA-PT-34-30-161-WG38172
ZTA-PT-34-30-209-WG38173
ZTA-PT-36-32-161-WG38178
ZTA-PT-36-32-209-WG38179
ZTA-PT-38-34-167-WG38180
ZTA-PT-38-34-217-WG38190
ZTA-PT-40-36-167-WG38191
ZTA-PT-40-36-217-WG38201
ZTA-PT-42-38-173-WG38203
ZTA-PT-42-38-225-WG38204
ZTA-PT-44-40-179-WG38208
ZTA-PT-44-40-233-WG38216
ZTA-PT-46-42-179-WG38220
ZTA-PT-46-42-233-WG38236
ZTA-P-18-105-WG35327
ZTA-P-20-105-WG35329
ZTA-P-22-105-WG35331
ZTA-PT-22-18-105-WG38041
ZTA-PT-26-22-105-WG38055
ZTA-DE-22-104-WG35506

 

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