Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01156-1
Product Name/Description	IntellaTip MiFi XP Asymmetric (N4) Curve Temperature Ablation Catheters Material Numbers: M004EPM4500N40, M004EPM4790N40, M004PM4500N40 and M004PM4790N40 Multiple Lot Numbers affected ARTG Number: 232994
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	26/11/2015
Responsible Entity	Boston Scientific Pty Ltd
Reason/Issue	Boston Scientific has received reports of bent distal tips, and in four cases, this situation resulted in exposed internal wires in the asymmetric curve models (known as N4) of IntellaTip MiFi XP. The most common clinical observation is prolongation of the procedure to exchange a bent catheter with a new device. Though no serious patient harms have been reported, a bent catheter tip or exposed internal wire could result in tissue damage to blood vessels and cardiac structures. This may result in cardiac or vascular perforation, with need for invasive intervention to prevent permanent damage or impairment.
Recall Action	Recall
Recall Action Instructions	Boston Scientific are advising users to inspect and quarantine any affected stock and return it to Boston Scientific. This action has been closed-out on 26/08/2016.
Contact Information	02 8063 8144 - Boston Scientific