NVT GmbH, FSN-CAPA 23-10, ALLEGRA Transcatheter Heart Valve

NVT has been informed that there has been a mix-up between an ALLEGRA THV 23 and an ALLEGRA THV 31.lf 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. An ALLEGRA THV 23 was found in the packaging of an ALLEGRA THV 31. Therefore NVT assumes that an ALLEGRA THV 31 is in an ALLEGRA THV 23 package. Based on the production data, the possibly affected products can be limited and identified (see Appendix 1 ). As a result, NVT has initiated a recall of the affected devices. This issue is related exclusively to the ALLEGRA THV. Patients who have al ready been treated with an affected device are not impacted by this action.