Advanta and Flixene Vascular Grafts
Brand(s)
Last updated
Summary
Product
Advanta and Flixene Vascular Grafts
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 |
|---|---|---|
| Advanta VXT PTFE Vascular Graft - Standard Wall | More than 10 numbers, contact manufacturer. | 22070 22018 22012 22075 22076 22059 22072 22114 22014 22115 |
| Flixene PTFE Vascular Graft GW Slider GDS | 483911 487678 484066 471874 473500 472387 479634 | 25061 |
| Flixene PTFE Vascular Graft GWT-GW Slider GDS-2 | 474008 471881 478487 | 25138 |
| Advanta VXT PTFE Vascular Graft - Thin Wall | 483479 482732 498630 476819 498305 473196 | 22227 22190 22186 |
Issue
Potential for the slider graft development system (GDS) swivel rod to separate from the slider GDS swivel core, or notable gaps between the slider GDS swivel rod and the slider GDS anchor. The issue is only associated with the slider GDS, which is used during implantation.
Recall start date: May 10, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Atrium Medical Corporation
40 Continental Blvd., Merrimack, New Hampshire, United States, 03054
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75551
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