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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00973-1
Product Name/Description NC Sprinter RX Balloon Dilatation Catheter ( Angioplasty balloon dilatation catheter)

Model Number: NCSP22512X

Lot Number: 207002011

ARTG 154737
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 16/09/2013
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue Medtronic has identified a labelling issue for lot number 207002011 of the NC Sprinter RX Balloon Dilatation Catheter, Model NCSP22512X, in which the compliance chart contained inside the package incorrectly references a 2.5mm balloon diameter instead of the correct 2.25mm diameter. If the affected product was utilised referencing the incorrect compliance chart, the target diameter of the balloon may be less than expected, resulting in suboptimal treatment. The situation would require further inflation at a higher pressure or the use of another balloon catheter to resolve the stenosis, resulting in longer procedural duration.
Recall Action Recall
Recall Action Instructions Medtronic is requesting users to return affected stock for replacement with unaffected product.
Contact Information 03 8851 1078 - Medtronic Australasia