Health product recall

Advanta and Flixene Vascular Grafts

Last updated

Summary

Product
Advanta and Flixene Vascular Grafts
Issue
Medical devices - Performance issue
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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