Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:26946
Brand Name:Axios Stents with delivery system
Model:
Affected:Multiple lots
Software version:
Recalling Organisation:Boston Scientific NZ Ltd
3 Diamond Street
Eden Terrace
Auckland 1021
Contact Information:0800 742 678
Manufacturer:Xlumena Inc
Brand Name:Axios Stents with delivery system
Model:
Affected:Multiple lots
Software version:
Recalling Organisation:Boston Scientific NZ Ltd
3 Diamond Street
Eden Terrace
Auckland 1021
Contact Information:0800 742 678
Manufacturer:Boston Scientific Corporation
Issue:During manufacturing the manufacturer identified that the rotating luer fitting at the distal end of the delivery system may become detached from the nose of the delivery system, which can occurduring device preparation, stent delivery,or delivery system removal.
Recall action type:Recall
Recall action:Product to be returned to supplier
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:30/11/2020
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