Medtronic Issues Three Simultaneous Recalls in China, Including Two Class I Actions

China Economic Net, November 22nd, by reporter Hanlu Han — On November 18th, the website of the National Medical Products Administration simultaneously released three product recall notices involving Medtronic, two of which were classified as Class I recalls, meaning the use of these medical devices may cause or has already caused serious health hazards.

Medtronic (Shanghai) Management Co., Ltd. reported that due to issues involving specific models and specific batches of products, the MMT-503EU remote controller has a potential security vulnerability. The manufacturer, Medtronic MiniMed, voluntarily recalled the Insulin Pump (registration number: Guo Medical Device Registration No. 20173141951). The recall level is Class I. According to the recall event report, the aforementioned security vulnerability may lead to the infusion of an unintended large dose of insulin to users.

Medtronic (Shanghai) Management Co., Ltd. reported that due to issues involving specific models and specific batches of products, there is insufficient weld penetration between the spindle and the hypotube. The manufacturer, Medtronic Inc., has initiated a voluntary recall of the Endurant II Stent Graft System (registration certificate number: Guo Qi Zhu Jin 20153132422). The recall is classified as Class I. Upon inquiry, it was found that all 201 products imported into China are currently stored in Medtronic's warehouse, have been isolated for handling, and will not enter the Chinese market in the future.

Medtronic (Shanghai) Management Co., Ltd. reported that due to issues related to specific models and specific batches of products, involving labeling/compliance problems, the manufacturer Medtronic Inc. voluntarily recalled the Defibrillation Lead (registration number: G20173217262). The recall level is Class III.