China NMPA Product Recall - Subcutaneous Implantable Defibrillator

Boston Scientific Corporation initiated a voluntary recall of its Subcutaneous Implantable Defibrillator, as announced by the National Medical Products Administration (NMPA) on February 28, 2022. The recall stems from a critical issue identified in specific models and batches of the device. Investigations revealed that low-voltage capacitors within these defibrillators could potentially lead to premature battery depletion. This defect poses a risk to patients, as it could compromise the device's ability to deliver life-saving therapy when needed.

The company's proactive measure to recall the affected products underscores its commitment to patient safety and compliance with medical device regulations overseen by the NMPA. The recall is classified as Level II, indicating a situation where use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Boston Scientific Corporation has provided detailed information regarding the affected product models and batch numbers in a "Medical Device Recall Event Report Form" to facilitate the efficient removal of these devices from circulation. This action ensures that healthcare providers and patients are aware of the potential risks and can take appropriate steps, in line with regulatory expectations for medical device safety and efficacy.