Voluntary recall of Lotus™ Valve System due to deployment issue

Boston Scientific Asia Pacific Pte Ltd would like to inform healthcare professionals of a voluntary recall of Lotus™ Valve System due to a higher than anticipated number of reports of early pin release prior to locking the valve in its final position. This will result in the valve needing to be resheathed and removed from the patient, thus prolonging the implant procedure. Replacement of the valve was successful in all complaints but one case where the patient died. There are no safety concerns for patients who were previously implanted with a Lotus™ Valve as it does not impact the performance of the implanted valve. It is only a potential issue during the implant procedure itself. Healthcare professionals are advised to return all unused affected devices to Boston Scientific and monitor patients implanted with this device as per normal clinical practice. Please refer to the letter for details.