Database updated: 3 November 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:29115
Brand Name:Catheter balloon inflation system, single-use
Model:
Affected:
Software version:
Recalling Organisation:Abbott Vascular Division of Abbott Medical New Zealand Limited
4 Pacific Rise
Mt Wellington
Auckland 1060
Contact Information:
Manufacturer:Abbott Vascular (USA)
Issue:The manufacturer has identified that specific lots of 20/30 INDEFLATORTM within associated Priority Packs may exhibit leaks and/or a loose connection at the rotating luer assembly or stopcock connection, which could lead to air ingress under vacuum.
Recall action type:Recall
Recall action:Product to be returned to supplier
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:15/3/2022
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