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

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-corporation/9f822cce-ca05-4650-bbad-e474704185e7/
Source feed: China

> China NMPA product recall for Neuroform 3 Intracranial Scaffold System (Trade Name: Neuroform 3) by Boston Scientific Corporation published May 19, 2010. Recall level: . Boston Scientific, Inc., issued a global Medical Device Notification concerning specific batches of 

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Neuroform 3 Intracranial Scaffold System Recall Event Report Form
- Company Name: Boston Scientific Corporation
- Publication Date: 2010-05-19
- Product Name: Neuroform 3 Intracranial Scaffold System (Trade Name: Neuroform 3)
- Recall Reason: A small number of Neuroform 3 intracranial stent systems exhibited a protruding core axis extending beyond the anterior catheter stabilizer. This core axis is highly visible and immediately noticeable to the user. If present, the Neuroform 3 intracranial stent system cannot be loaded onto the guidewire, and the user must remove it. Secondary testing confirmed that the presence of the core axis does not affect the sterilization of the final product and, once removed, does not negatively impact the stent system's function. Therefore, the presence of the core axis does not pose a danger to the patient, as physicians can remove it directly before normal instrument use.
- Discovering Company: Boston Scientific
- Manufacturing Company: Boston Scientific Corporation
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/boston-scientific-corporation/29488af7-a1d7-4d3b-a8ab-1f12fddb5e4b/