# China NMPA Product Recall - Disposable Prostate Steam Therapy Device (Rezum Delivery Device)

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-corporation/4971d789-9a06-4e35-b6df-985351bec423/
Source feed: China

> China NMPA product recall for Disposable Prostate Steam Therapy Device (Rezum Delivery Device) by Boston Scientific Corporation published November 29, 2024. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) announced a Class III voluntary recall initiated

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Boston Scientific Corporation is voluntarily recalling single-use prostate steam therapy devices.
- Company Name: Boston Scientific Corporation
- Publication Date: 2024-11-29
- Product Name: Disposable Prostate Steam Therapy Device (Rezum Delivery Device)
- Recall Level: Level 3 Recall
- Recall Reason: Reasons for correcting published information
- Discovering Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Manufacturing Company: Boston Scientific Corporation
- Summary: The National Medical Products Administration (NMPA) announced a Class III voluntary recall initiated by Boston Scientific Corporation for its single-use prostate steam therapy device, the Rezum Delivery Device (National Medical Device Registration Certificate No. 20223090123). This recall, reported by Boston Scientific International Medical Trading (Shanghai) Co., Ltd., was prompted by a correction to previously released information concerning the device. The NMPA's announcement, dated November 29, 2024, clarifies that the products involved in this recall were not imported into China, thereby limiting direct impact on the Chinese market. This action falls under the regulatory oversight of the NMPA, ensuring compliance and public safety within the medical device industry. Detailed information regarding specific models, specifications, and batches is available in the associated "Recall Event Report Form." This proactive measure by Boston Scientific Corporation, guided by NMPA regulations, underscores the industry's commitment to addressing discrepancies and maintaining accurate product information to safeguard patient well-being.

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