Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, NVT GmbH, has issued a medical device safety alert concerning ALLEGRA Transcatheter Heart Valve (ALLEGRA THV 23) [Ref.: THV-AO0023G1RE] [HKMD No.: 220426].
According to the manufacturer, there has been a mix-up between an ALLEGRA THV 23 and an ALLEGRA THV 31. If not identified prior to use, the mix up of an ALLEGRA THV size may potentially lead to complications, which could cause a serious deterioration in the patient's state of health.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 26 Jul 2023