Devices

Cook brand Zenith AAA Bifurcated main body graft with the H&L-B; One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 22 mm - iliac leg diameters 11 mm - main body lengths cntralateral limb 74mm ipsilateral limb 133 mm - delivery system 18 FR; Catalog no. TFB-22-74.

Model / Serial
Lots F1545880, F1545881, F1555822, F1556920, F1560071 and F1560072.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide, Canada, Denmark and Japan.
Product Description
Cook brand Zenith AAA Bifurcated main body graft with the H&L-B; One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 22 mm - iliac leg diameters 11 mm - main body lengths cntralateral limb 74mm ipsilateral limb 133 mm - delivery system 18 FR; Catalog no. TFB-22-74.
Manufacturer
Cook, Inc.
1 Event
- Recall of Cook brand Zenith AAA Bifurcated main body graft with the H&L-B; One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 22 mm - iliac leg diameters 11 mm - main body lengths cntralateral limb 74mm ipsilateral limb 133 mm - delivery system 18 FR; Catalog no. TFB-22-74.

Manufacturer

Cook, Inc.

Manufacturer Address
Cook, Inc., 750 Daniels Way, Bloomington IN 47404-9120
Source
USFDA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)