China NMPA Product Recall - Detachable spring coil (Product name: Matrix)

The National Medical Products Administration (NMPA) issued a recall report regarding Boston Scientific Corporation's Matrix® and Matrix2® removable coils, specifically the Matrix2 Standard 2D SR 8mm x 30cm coil. Published on November 3, 2010, this action addresses two complaints confirming degradation of the bioabsorbable polymer coating, PGLA, at the product's expiration date. Although no patient injuries have been reported, this degradation poses a clinical risk of foreign body embolism during implantation if loosened PGLA material enters the circulatory system. The potential clinical consequences range from no effect to a serious stroke, with the latter considered extremely low probability.

Under the NMPA's regulatory framework, Boston Scientific, through its Chinese subsidiary, is implementing corrective actions. These include identifying affected customers based on shipping history, delivering notifications via mail, fax, or visits, and arranging for the return of the affected products. The company expects to complete these recall activities by January 13, 2011, to ensure patient safety regarding the coils used for embolization of intracranial aneurysms and other neurovascular malformations.