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Home NMPA Announces Recent Medical Device Recalls by Medtronic, GE Healthcare, and Maquet (InterVascular)

NMPA Announces Recent Medical Device Recalls by Medtronic, GE Healthcare, and Maquet (InterVascular)

Apr 20, 2025 11:00 CST Updated 11:00
Medtronic

Medical Device Manufacturer

Recently Released by NMPAMedtronic, GE, Maquet and InterVascular (Maquet) Four Companies' ProductsRecall Information. Among them, Medtronic products are classified as a Level 1 recall, whileMaquet and InterVascular products are subject to a Class II recall, while GE products are subject to a Class III recall.Maquet, InterVascular and GEThe product has not been imported into China, so patients in China will not be affected by quality issues.Life and Health. AndMedtronic products enter China, and these products significantly impact patient health. According to FDA disclosed information, the products...The issue with the Gong Luer connector may potentially cause delays, strokes, or even death, thus warranting serious attention.
【01】Medtronic
Reason for Recall:Suspected Scratches and Loose Plastic Material in the Male Luer Connector of the Antegrade Perfusion Cannula
Recall Level: Class I
Recall Quantity: 133 boxes
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【02】Maquet
Recalled Product: Endoscopic Vessel Harvesting System
Reason for Recall:Risk of rupture during the use of ceramic C-ring products
Recall Level: Level 2
Number of recalls: 0 sets
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【03】InterVascular（Maquet
Recalled Product: Artificial Vascular Patch
Reason for Recall:Unclear description of the product's inner and outer sides
Recall Level: Level 2
Number of Recalls: 0 sets
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【04】GE
Recalled Product: Mobile C-arm X-ray Machine
Reason for Recall:The sum of the deviation values of the length and width of the X-ray field of Product X relative to the field of view does not comply with the provisions of IEC 60601-2-54.
Recall Level: Level III
Number of recalls: 0 sets
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