Urgent Field Safety Notice For Figulla Flex II Asd By Occlutech Gmbh

Recall Summary Occlutech GmbH is issuing an urgent field safety notice for Figulla Flex II ASD devices, which are medical implants used to close heart defects. This is a Class I recall, the most serious classification. The affected devices were distributed in Germany and the EU.

Recalling firm
Occlutech GmbH
Product
Figulla Flex II ASD
Reason
Urgent Field Safety Notice for Figulla Flex II ASD by Occlutech GmbH
Classification
Class I
Category
medical device recall
Country
Germany
Agency
BFARM
Recall date
2026-07-02
Status
Ongoing
Distribution
Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/4835f41c-1f44-4ec1-a431-d32624151a7f