China NMPA Product Recall - Neuroform 3 Intracranial Scaffold System (Trade Name: Neuroform 3)

Boston Scientific, Inc., issued a global Medical Device Notification concerning specific batches of its Neuroform 3 Intracranial Stent System. This action, reported to the National Medical Products Administration (NMPA) on May 19, 2010, addressed a manufacturing defect where a non-functional spindle could protrude beyond the anterior catheter stabilizer. This spindle, a temporary manufacturing aid, would prevent the stent system from being loaded onto a guidewire, necessitating its removal by the user before clinical application.

While the spindle's presence did not compromise product sterilization or stent functionality once removed, thus posing no direct patient danger, it represented a significant deviation from expected product readiness. Affected regions included China, where 75 units were imported and 24 sold, alongside other countries like Argentina, Australia, Belgium, Brazil, and Canada.

Boston Scientific's corrective action involved identifying 28 affected customers and delivering detailed notifications, requesting signed confirmation forms. This proactive customer outreach was successfully completed by March 12, 2010, ensuring all relevant parties were informed and the issue was effectively managed in accordance with regulatory expectations.