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

Stryker Neurovascular, through its affiliate Stryker (Beijing) Medical Devices Co., Ltd., initiated a voluntary Class III recall of its Target brand releasable coils, as reported by the National Medical Products Administration (NMPA) on July 15, 2016. The recall pertains to specific batches of Target Nano releasable coils.

The primary issue identified was the potential for the anti-unwinding wire within these coils to break, leading to the coil stretching and unwinding. Investigations revealed that during routine electrical positioning testing, these particular batches of coils were exposed to temperatures exceeding the melting point of the anti-unwinding wire. This excessive heat caused the wire to melt and subsequently break, compromising the device's integrity and function.

This recall action falls under the regulatory oversight of the NMPA, referencing registration number CFDA (Imported) No. 20133773913. Stryker Neurovascular is undertaking this voluntary recall to address the critical safety concern. Further details regarding the affected product models, specifications, and batch numbers are available in the "Medical Device Recall Event Report Form." The required action involves the retrieval of all affected units from the market to prevent potential patient harm resulting from device malfunction.