China NMPA Product Recall - Brain protection device

The National Medical Products Administration (NMPA) announced a Class II voluntary recall initiated by Invatec S.p.A. of Italy, as reported by Medtronic (Shanghai) Management Co., Ltd. on October 23, 2023. The recall impacts certain brain protection devices (National Medical Device Registration Certificate No. 20153034216).

The core issue stems from the incorrect orientation of two labels on some of these devices. This labeling error presents a critical risk, as it could lead to the misidentification of the proximal and distal inflation and deflation ports. Such confusion during clinical use could result in improper device operation, potentially compromising patient safety during procedures requiring brain protection.

Operating under the NMPA's regulatory framework, Invatec S.p.A. is undertaking this voluntary action to rectify the defect. A Class II recall indicates that the product defect has the potential to cause temporary or medically reversible adverse health consequences, or that the likelihood of serious adverse health consequences is remote. Medtronic (Shanghai) Management Co., Ltd. is managing the recall, with comprehensive details on affected product models, specifications, and batch numbers available in the official "Medical Device Recall List" and an accompanying "Medical Device Recall Event Report Form." This action underscores a commitment to patient safety and product integrity.