# China NMPA Product Recall - Curved Visual Two-Way Adjustable Curved Guiding Sheath

Source: https://www.globalkeysolutions.net/records/china_product_recall/biosense-webster-inc/642820a3-383d-4efe-b066-da729adff5c6/
Source feed: China

> China NMPA product recall for Curved Visual Two-Way Adjustable Curved Guiding Sheath by Biosense Webster Inc. published March 11, 2021. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) announced on March 11, 2021, a voluntary Class I

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling its curved, visually adjustable, bidirectional curved guide sheath.
- Company Name: Biosense Webster Inc.
- Publication Date: 2021-03-11
- Product Name: Curved Visual Two-Way Adjustable Curved Guiding Sheath
- Recall Level: Level 2 Recall
- Recall Reason: Preliminary user feedback indicates that complaints of hemostatic valve displacement are higher than expected when dilators or other instruments are introduced into the VIZIGO guiding sheath. Hemostatic valve displacement may cause minor bleeding in patients, and in very extreme cases, air ingress may lead to air embolism.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Biosense Webster Inc.
- Summary: The National Medical Products Administration (NMPA) announced on March 11, 2021, a voluntary Class II recall initiated by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. This action concerns their Visible Two-Way Adjustable Guided Sheath (VIZIGO). The recall stems from user feedback indicating a higher-than-expected number of complaints regarding hemostatic valve displacement. This issue may occur when dilators or other devices are introduced into the sheath, potentially leading to minor patient bleeding. In extreme, albeit rare, cases, air ingress could result in an air embolism. However, the company has confirmed that no serious adverse events or air embolisms linked to this specific issue have been reported globally or within China. Operating under the NMPA regulatory framework, Biosense Webster, Inc., a Johnson & Johnson entity, initiated this recall as an on-site safety notification, not a full product withdrawal. This action ensures healthcare facilities are informed of the potential issue, enabling them to implement necessary precautions without removing the product from circulation entirely. Detailed information on affected product models, specifications, and batch numbers is available in the associated Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/biosense-webster-inc/1e41796e-2ddf-4c5f-ba8b-efc71a994f80/