China NMPA Product Recall - balloon guiding catheter

Stryker Neurovascular initiated a voluntary Class III recall for its Balloon Guiding Catheters, as reported by the National Medical Products Administration (NMPA) on January 24, 2019, based on a company report dated November 22, 2016. The recall stemmed from a mispackaging issue where four 8F balloon guiding catheters (batch number 0000010779) were incorrectly placed inside packaging intended for 9F catheters. These catheters are designed to assist in inserting and guiding intravascular catheters in the peripheral or neurovascular system, and can also provide temporary vascular occlusion or serve as a retrieval device channel. While the mispackaging affected products distributed in regions such as Germany, Australia, and Italy, Stryker (Beijing) Medical Devices Co., Ltd. confirmed that no affected products were manufactured, imported, or sold within China. Consequently, the company's required actions in China were limited to reporting the incident to the State Food and Drug Administration and the Beijing Municipal Food and Drug Administration, with plans to publish this information on their respective websites. No further recall measures or product retrieval actions were necessary within China due to the absence of affected units in the local market. The regulatory framework, primarily governed by the NMPA, mandated this reporting despite the lack of direct impact on the Chinese market.