Product Recall for Begraft Coronary Stent Graft System

A Dear Healthcare Professional Letter has been issued by Innotronik Singapore Pte Ltd to inform healthcare professionals that the product owner of Begraft Coronary Stent Graft System, Bently InnoMed GmbH, has initiated a product recall for specific lots of the devices. There is a potential for the occurrence of a pinhole during the inflation of the balloon, hence, the complete expansion of the stent graft to the labelled nominal diameter cannot be guaranteed. If the stent graft cannot be completely expanded to the labelled nominal diameter, it may have limited or no performance function in the emergency situations the product is indicated for. The incompletely expanded stent graft may continue to migrate in the coronary system due to limited wall contact. In addition, if post-dilatation using another balloon catheter is not possible, open heart surgery may be required as the acute coronary artery perforation, acute coronary artery rupture, coronary artery aneurysm and coronary bypass-vein graft aneurysm cannot be sufficiently sealed. Already implanted products are not concerned by this safety information. No complaints, patient injuries or deaths have been reported with regard to the described failure mode at this time. Healthcare professionals are advised to stop using the affected devices and quarantine them for return to Innotronik. Please refer to the letter for details. Published: 20 May 2020

Dear Healthcare Professional Letters