NMPA Announces Class II Recalls Involving Maquet, Medtronic, and Covidien

China Economic Net, February 1 (Reporter Hanlu) -- On January 31, the National Medical Products Administration (NMPA) released a batch of recall information, including four Level II recalls, involving brands such as Maquet, Medtronic, and Covidien.

According to the severity of medical device defects, medical device recalls are divided into: Level 1 Recall: The use of the medical device may or has already caused serious health hazards; Level 2 Recall: The use of the medical device may or has already caused temporary or reversible health hazards; Level 3 Recall: The use of the medical device presents a smaller possibility of causing harm but still requires a recall.

Maquet (Shanghai) Medical Equipment Co., Ltd. reported that due to the involvement of specific models and specific batches of products posing a risk of electrical leakage, Maquet Cardiopulmonary GmbH, the manufacturer, has voluntarily recalled medical physical warming devices (registration certificate number: GuoXieZhuJin 20162451786). The recall level is Level II.

Medtronic (Shanghai) Management Co., Ltd. reported that due to issues with specific models and batches of products being unable to restart properly, the manufacturer, Medtronic Inc., has initiated a voluntary recall of implantable deep brain neurostimulators (registration certificate number: Guo Medical Device Registration Approval 20223120364). The recall level is Class II.

Covidien Medical Devices International Trade (Shanghai) Co., Ltd. reported that due to issues involving specific models and specific batches of products with potential needle breakage, the manufacturer Covidien LLC has initiated a voluntary recall of the V-loc 180 Absorbable Reload / V-loc PBT Non-Absorbable Reload for endoscopic staplers (registration certificate numbers: National Medical Device Registration No. 20153651978, National Medical Device Registration No. 20153021978). The recall is classified as Level II.

Maquet (Shanghai) Medical Equipment Co., Ltd. reported that due to issues involving specific models and specific batches of products, which have a problem of inability to ventilate, the manufacturer Maquet Critical Care AB has initiated a voluntary recall of anesthesia machines (Registration Certificate No.: China Medical Device Registration No. 20163082966, China Medical Device Registration No. 20223080583). The recall level is Class II.