Medtronic, Sekisui Medical, and Boston Scientific Initiate Voluntary Recalls Amid IPO Filings

1. Medtronic Inc. voluntarily recalls antegrade perfusion catheters

Medtronic (Shanghai) Limited reported that due to packaging seal issues, the manufacturer Medtronic Inc. initiated a Level 2 recall of its Cardioplegia Delivery Cannula (Registration No.: 20153101305). The products involved in this recall were not imported into China. For specific model, specifications, batch numbers, and other detailed information, please refer to the Medical Device Recall Report.

Attachment: Medical Device Recall Incident Report Form

2. SEKISUI MEDICAL CO., LTD. Initiates Voluntary Recall of High-Density Lipoprotein Cholesterol Assay Kit (Direct Method)

SEKISUI MEDICAL TECHNOLOGY (CHINA) LTD. reported that due to changes in labeling information within Japan, the manufacturer SEKISUI MEDICAL CO., LTD. is voluntarily recalling its High-Density Lipoprotein Cholesterol Assay Kit (Direct Method) Cholestest N HDL (Registration No. 20162401433). The recall is classified as a Level Three Recall. The products involved in this recall were not imported into China. For specific model, specifications, batch numbers, and other detailed information, please refer to the Medical Device Recall Report Form.

Attachment: Medical Device Recall Incident Report Form

3. Boston Scientific Corporation Initiates Voluntary Recall of Transcatheter Implantable Aortic Valve Delivery Catheters and Other Products

Boston Scientific International Medical Trading (Shanghai) Co., Ltd. reported that due to the reason of updating the instructions, the manufacturer Boston Scientific Corporation voluntarily recalled its Transcatheter Implantable Aortic Valve ACURATE neo2? Aortic Valve (Registration No. 20243130406), and Transcatheter Implantable Aortic Valve Delivery Catheter ACURATE neo2? Transfemoral Delivery System (Registration No. 20243030548). The recall level is Class III recall. For detailed information regarding the models, specifications, and batches of the affected products, please refer to the "Medical Device Recall Event Report Form."

Attachment: Medical Device Recall Event Report Form

November 15, 2024