Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:25609
Brand Name:NC TREK RX Coronary Dilatation Catheter
Model:balloon diameters 4.0mm, 4.5mm and 5.0mm
Affected:
Software version:
Recalling Organisation:Abbott Vascular Division of Abbott Laboratories (NZ) Ltd
Ground Floor, Building D
4 Pacific Rise
Mount Wellington
Auckland 1060
Contact Information:0800 827 285
Manufacturer:Abbott Vascular (USA)
Issue:The manufacturer has become aware of some identified lots that may exhibit difficulty or inability to deflate the balloon due to weaker material proximal to the balloon bond resulting from excess heat exposure during manufacturing.
Recall action type:Recall
Recall action:Product to be returned to supplier
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:29/1/2020
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