China NMPA Product Recall - Releaseable coil (Product name: Target)

Stryker Neurovascular initiated a voluntary Class III recall of its "Target" brand releasable coils, specifically certain batches of the "Target Nano" models, as reported by the National Medical Products Administration (NMPA). The recall was prompted by an identified manufacturing issue where the anti-unwinding wire in these coils could break. This defect arose during routine electrical positioning testing when the coils were inadvertently exposed to temperatures exceeding the melting point of the anti-unwinding wire. The excessive heat caused the wire to melt and break, potentially leading to the coil stretching and unwinding, posing a safety concern. The incident was reported on June 17, 2016, with the NMPA publishing the recall information on July 15, 2016. The affected product, registered under CFDA (Imported) No. 20133773913, is intended for use in endovascular, neurovascular, and peripheral vessels. The recall extends to various regions including the EU, Japan, China, and the USA, with 1136 units sold in China. Stryker Neurovascular's required action involves retrieving all affected products for unified processing to address the identified manufacturing deficiency and ensure patient safety.