Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its IntellaTip MiFi XP Asymmetric (N4) Curve Temperature Ablation Catheters [Material number (UPN): M004EPM4500N40, M004EPM4790N40].
The manufacturer has initiated a recall for all N4 curves of the IntellaTip MiFi XP Temperature Ablation Catheters. The manufacturer 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.
According to the manufacturer, the most common clinical observation is prolongation of the procedure to exchange a bent catheter with a new device. A bent catheter tip or exposed internal wire could result in tissue damage to blood vessels and cardiac structures.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 26 November 2015