Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01053-1
Product Name/Description Encore 26 Advantage Kit & Encore 26 Advantage Kit, 5 pack (Used to perform general intravascular procedures)

Encore 26 Advantage Kit
Material Number: H74904527011
Catalogue Number: 04527-01

Encore 26 Advantage Kit (5 pack)
Material Number: H74904527052
Catalogue Number: 04527-05

Multiple Lot Numbers

Expiration dates between 13 August 2014 & 30 September 2014

Manufactured between 3 August 2012 & 18 September 2012

ARTG Number: 159833
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 29/10/2012
Responsible Entity Boston Scientific Pty Ltd
Reason/Issue Users of the Encore 26 Advantage Kits which were manufactured between August 3 2012 and September 18 2012 may experience difficulty in passing guidewires through the insertion tool which is included in the Encore 26 Advantage Kits. The difficulty to pass guidewires, especially J tipped guidewires, through the insertion tool is caused by lack of smoothness within the hub/hypo tube transition in some devices.
Recall Action Recall for Product Correction
Recall Action Instructions The sponsor is provided work around instructions for users to follow.
Contact Information 02 8063 8340 - Boston Scientific