China NMPA Product Recall - Avalus Bioprosthesis artificial heart valve

Medtronic Inc. has initiated a voluntary Class III recall of its Avalus Bioprosthesis artificial heart valve (National Medical Device Registration Certificate No. 20223130018), as reported by Medtronic (Shanghai) Management Co., Ltd. to the National Medical Products Administration (NMPA). The recall stems from an identified process error that resulted in users in certain regions not receiving the correct instructions for use with specific product units. This deficiency in accompanying documentation poses a potential risk to the safety and proper application of the medical device. The regulatory oversight for this recall falls under the purview of the National Medical Products Administration in China. While the document specifies a publication date of July 4, 2023, and identifies the recall, it does not provide explicit dates for any inspections related to this issue. The required action by Medtronic Inc. is the comprehensive recall of the affected artificial heart valve products to mitigate potential user safety concerns arising from incorrect usage instructions. Further detailed information regarding specific affected models, specifications, and packaging is available in the "Medical Device Recall Event Report Form" attachment referenced in the NMPA's announcement. This voluntary action underscores Medtronic's commitment to product safety and regulatory compliance.