Zenith Branch Endovascular Graft Iliac Bifurcation
Brand(s)
Last updated
Summary
Product
Zenith Branch Endovascular Graft Iliac Bifurcation
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Zenith Branch Endovascular Graft Iliac Bifurcation | All lots. | ZBIS-12-45-41 ZBIS-12-61-58 ZBIS-10-45-41 ZBIS-10-45-58 ZBIS-12-45-58 ZBIS-12-61-41 |
Issue
Tip of the catheter, which is an indwelling component of the Zenith Branch Iliac Endovascular (ZBIS) and the Bifurcated Iliac sidebranch CMD can split / break during device preparation or during the endovascular procedure. This recall is specific to all lots manufactured prior to March 8, 2023.
Recall start date: March 23, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
William A. Cook Australia, Pty. Ltd.
95 Brandl Street, Queensland, Australia, 4113
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73410
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