# China NMPA Product Recall - Implantable pacing electrode catheters and implantable cardiac pacemakers

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-corporation/8840740f-0561-4472-be7e-1f5447c9d4c3/
Source feed: China

> China NMPA product recall for Implantable pacing electrode catheters and implantable cardiac pacemakers by Boston Scientific Corporation published February 22, 2011. Recall level: . The National Medical Products Administration (NMPA) issued a notice on February 22, 2011, regarding 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Boston Scientific has recalled its implantable pacing electrode catheters and implantable pacemakers.
- Company Name: Boston Scientific Corporation
- Publication Date: 2011-02-22
- Product Name: Implantable pacing electrode catheters and implantable cardiac pacemakers
- Recall Reason: The Chinese label for the implantable pacing electrode catheter (model: 4457) does not match the English label; the Chinese label model number is incorrect (incorrectly labeled as: model 4480), while other information is correct. The serial number on the Chinese label for the implantable pacemaker (model: 1291, serial number 156509) is incorrect. The production date and expiration date on the Chinese label for the implantable pacemaker (model: 1294, serial number 964077) are reversed.
- Discovering Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Manufacturing Company: Boston Scientific Corporation
- Summary: The National Medical Products Administration (NMPA) issued a notice on February 22, 2011, regarding a voluntary recall initiated by Boston Scientific International Medical Trading (Shanghai) Co., Ltd., on behalf of its manufacturer, Boston Scientific Corporation, USA. The recall involves specific lots of implantable pacing electrode catheters (model 4457) and implantable cardiac pacemakers (models 1291 and 1294).  The primary reason for this recall stems from critical labeling errors on the Chinese product labels. For the implantable pacing electrode catheter, the Chinese label incorrectly displayed the model number as 4480 instead of the correct 4457. Regarding the implantable cardiac pacemaker model 1291 (serial number 156509), an incorrect serial number was present on its Chinese label. Furthermore, for pacemaker model 1294 (serial number 964077), the production and expiration dates were erroneously reversed on the Chinese label. These inaccuracies could lead to product identification issues. Under the regulatory oversight of the NMPA, Boston Scientific voluntarily initiated this recall to address these non-conformances. While the document does not specify inspection dates, it details the company's proactive measure. Provincial regulatory bodies were instructed to acknowledge and monitor the recall process. This action underscores the importance of accurate product information for medical devices distributed in China, ensuring patient safety and regulatory compliance.

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