China NMPA Product Recall - Subcutaneous implantable cardioverter defibrillator

Boston Scientific Corporation initiated a Class I global voluntary recall for its Subcutaneous Implantable Cardioverter Defibrillator (SID), specifically model 1010, as reported by the National Medical Products Administration (NMPA) on July 3, 2017. This critical action stems from a memory malfunction identified in the device, which led to atypical and repeated power outputs. Tragically, this malfunction was directly linked to the death of a patient in the United States in May 2017. The affected devices, totaling 54 units in China (National Medical Device Registration Certificate 20153212410), are part of a broader global recall due to the serious health risks posed by the malfunction. Under the NMPA's regulatory oversight, Boston Scientific International Medical Trade (Shanghai) Co., Ltd. is managing the recall. As required actions, Boston Scientific is communicating directly with affected customers, providing detailed explanations of the recall's reasons and outlining necessary steps. Crucially, the company is developing a software update to resolve the identified memory malfunction. Once available, Boston Scientific will arrange for all affected SIDs currently in use to receive this essential software upgrade. It is important to note that this recall focuses on corrective software measures and does not require the physical return of any products.