China NMPA Product Recall - Detachable spring coil (Product name: Matrix²)

The National Medical Products Administration (NMPA) announced on June 1, 2011, a voluntary recall initiated by Boston Scientific International Medical Trade (Shanghai) Co., Ltd., for specific batches of its "Matrix2" detachable coils. The manufacturer is Boston Scientific Corporation, USA. The recall stemmed from the premature degradation of the PGLA (polyethylene glycol-polylactic acid) coating on the coils, which occurred before the products' expiration date. Two complaints confirmed this issue, though no patient injuries were reported. The primary concern identified was the potential for PGLA foreign body embolism if degraded material entered the circulatory system during implantation, posing a risk that could range from minor to a serious stroke, albeit with a very low likelihood of severe outcomes.

Under the oversight of the NMPA (formerly the State Food and Drug Administration), Boston Scientific implemented a recall plan. This involved identifying all 101 affected customers through shipping records, notifying them via various channels, and facilitating the return of the compromised products. The recall operation was largely completed by December 27, 2010, with 226 affected products returned from 25 customers. Provincial food and drug administrations were concurrently instructed to enhance their supervision and management of similar medical devices to ensure patient safety.