Occlutech GmbH, FSCA-2024-002, Figulla Flex II ASD Occluder

Occlutech has identified that products affected by this corrective action have a size recommendation of ODS III (REF 98DS006) on the label of the Procedure Pack box and the sterile pouch of the implant that might lead to incompatibility. The recommendation and labelling of the Occlutech Delivery Set with REF 51DS007 as 7F on the affected Procedure Pack box and the sterile pouch of the affected implant remains correct as per specification. It was identified that there were some discrepancies between the labelled size for ODS III and the results from internal tests. The size of compatible delivery system on the labels is too small. Instead of the labelled 6F ODS III size, a minimum size of 7F ODS III should be used. The usage of an undersized delivery system for the implantation of the Figulla Flex II ASD could result in damage to the Occluder device.