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

Stryker Neurovascular, through its Chinese affiliate Stryker (Beijing) Medical Devices Co., Ltd., initiated a Class III voluntary recall for specific batches of its Target brand releasable coils. This action was formally reported to the National Medical Products Administration (NMPA) on June 17, 2016, and publicly announced on July 21, 2016. The recall was prompted by a critical manufacturing issue: during routine electrical positioning testing, an equipment malfunction caused certain Target Nano coils to be exposed to temperatures exceeding the melting point of their internal anti-unwinding wire. This excessive heat led to the wire melting and fracturing, creating a risk that the coil could stretch and unwind. Such a defect could compromise the device's intended function, which is to address blood flow abnormalities in neurovascular and peripheral vessels. Under the regulatory framework of the NMPA (previously CFDA), a Class III recall indicates a situation where use of, or exposure to, a violative product is not likely to cause adverse health consequences. As a required action, Stryker Neurovascular is coordinating the return of all identified affected products for unified processing, demonstrating its commitment to product safety and regulatory compliance.