Medtronic Issues Class I Recall in China for Antegrade Cardioplegia Cannula Due to Loose Plastic Material Risk

Apr 18, 2025 18:34 CST Updated 18:34

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Source:National Medical Products Administration

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The National Medical Products Administration (NMPA) has recently released recall information for four medical device companies, including Medtronic.Level 1 Recall。

Medtronic Issues Level 1 Recall for 133 Units of Antegrade Perfusion Catheters

Medtronic (Shanghai) Limited reported that due to the discovery of suspected scratches and loose plastic material in the male luer connector used for antegrade perfusion cannulas, the manufacturer MEDTRONIC INC. has initiated a voluntary recall of its Cardioplegia Delivery Cannula (China Medical Device Registration No. 20153101305). The recall is classified as a Level 1 recall.

Maquet Medical Equipment (Suzhou) Co., Ltd. Issues Level 2 Recall of Endoscopic Vessel Harvesting System

Maquet (Shanghai) Medical Equipment Co., Ltd. reported that due to the risk of rupture of the product's ceramic C-ring during use, Maquet Cardiovascular LLC, the manufacturer, voluntarily recalled its Endoscopic Vessel Harvesting System (China Medical Device Registration No. 20173011945). The recall level is Class II.

InterVascular SAS Issues Class II Recall for Vascular Graft Patches and Related Products

Maquet (Shanghai) Medical Equipment Co., Ltd. reported that due to the unclear description of the inner and outer sides of the product, the manufacturer InterVascular SAS initiated a voluntary recall of its Vascular Patches (China Medical Device Registration No. 20173137193) and Vascular Patches (China Medical Device Registration No. 20173467193). The recall level is Class II.

GE Orthopedic Equipment Medical Systems Company Issues Voluntary Recall of Mobile C-arm X-ray Machines and Other Products

GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. reported that due to the sum of the deviation values of the product's X-ray field relative to the length and width of the field of view not meeting the requirements specified in IEC 60601-2-54, the manufacturer GE OEC Medical Systems, Inc. voluntarily recalled its Mobile C-arm X-ray system (Registration No.: GuoXieZhuJin 20193060162, GuoXieZhuJin 20243060420). The recall level is classified as a Level III recall.

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