# China NMPA Product Recall - Direxion Torqueable Microcatheter and Direxion HI-FLO Torqueable Microcatheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-corporation/0f7c5b5e-180b-49c1-8c2f-a687d4ad29f1/
Source feed: China

> China NMPA product recall for Direxion Torqueable Microcatheter and Direxion HI-FLO Torqueable Microcatheter by Boston Scientific Corporation published June 14, 2024. Recall level: Level 2 Recall. Boston Scientific Corporation has initiated a voluntary Class II recall for its Direxion Torqueable 

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Boston Scientific Corporation initiates voluntary recall of torsion-resistant microcatheters
- Company Name: Boston Scientific Corporation
- Publication Date: 2024-06-14
- Product Name: Direxion Torqueable Microcatheter and Direxion HI-FLO Torqueable Microcatheter
- Recall Level: Level 2 Recall
- Recall Reason: The presence of adhesive in the working channel of the microcatheter interface may cause sticky particles to enter the patient's bloodstream.
- Discovering Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Manufacturing Company: Boston Scientific Corporation
- Summary: Boston Scientific Corporation has initiated a voluntary Class II recall for its Direxion Torqueable Microcatheter and Direxion HI-FLO Torqueable Microcatheter. This action, publicly announced by the National Medical Products Administration (NMPA) on June 14, 2024, addresses a critical product defect. The main issue identified is the presence of adhesive within the working channel of the microcatheter interface, which presents a significant patient safety concern. This defect carries the risk that sticky particles could detach and potentially enter a patient's bloodstream during medical procedures, leading to potential adverse health consequences. Under the NMPA's regulatory framework, a Level II recall signifies that the use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. Boston Scientific Corporation is required to identify, quarantine, and remove all affected products from circulation. Further details regarding specific product models, specifications, and batch numbers are provided in the accompanying Medical Device Recall Event Report Form. This recall highlights the company's proactive approach to ensuring product integrity and patient safety in compliance with NMPA regulations.

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