# China NMPA Product Recall - MEGA Intra-Aortic Balloon Catheters and Accessories

Source: https://www.keypedia.com/records/china_product_recall/datascope-corp/16407608-f1a9-4ffe-9fad-1ca13fd59886
Source feed: China

> China NMPA product recall for MEGA Intra-Aortic Balloon Catheters and Accessories by Datascope Corp published October 17, 2024. Recall level: Level 3 Recall. Datascope Corp. has initiated a voluntary Class III recall of its MEGA Intra-Aortic Balloon Catheter

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Datascope Corp., a medical company, is voluntarily recalling its intraaortic balloon catheters and accessories.
- Company Name: Datascope Corp
- Publication Date: 2024-10-17
- Product Name: MEGA Intra-Aortic Balloon Catheters and Accessories
- Recall Level: Level 3 Recall
- Recall Reason: The labels on the inner and outer packaging of the product are inconsistent.
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: Datascope Corp
- Summary: Datascope Corp. has initiated a voluntary Class III recall of its MEGA Intra-Aortic Balloon Catheters and associated accessories. The recall, reported by Maikewei (Shanghai) Medical Equipment Co., Ltd. to the National Medical Products Administration (NMPA) on October 17, 2024, stems from critical inconsistencies identified between the inner and outer packaging labels of the affected devices. This labeling discrepancy necessitates corrective action under regulatory standards to ensure product identification accuracy. The regulatory framework overseeing this action is the National Medical Products Administration, which monitors medical device compliance and safety. Datascope Corp. confirmed that the specific batches of products involved in this event were not imported into the Chinese market. The required action involves a comprehensive voluntary recall process, with specific models, specifications, and batch details further outlined in the "Medical Device Recall Event Report Form." This proactive measure by Datascope Corp. aims to uphold product integrity and adherence to labeling regulations, preventing potential misidentification or misuse of medical devices.

Company: https://www.keypedia.com/companies/datascope-corp/142b819e-10e1-4fd4-ad34-3e11deb1f442