# China NMPA Product Recall - Pulse Generator implantable cardiac pacemaker

Source: https://www.globalkeysolutions.net/records/china_product_recall/st-jude-heart-rhythm-management-co-ltd/ed4052d5-74b2-4624-b605-d585b784445c/
Source feed: China

> China NMPA product recall for Pulse Generator implantable cardiac pacemaker by St. Jude Heart Rhythm Management Co., Ltd. published October 24, 2023. Recall level: Level 1 Recall. St. Jude Medical Cardiac Rhythm Management Division, in cooperation with Abbott Medical Products (Sh

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: St. Jude Medical Cardiac Rhythm Management Division is issuing a voluntary recall for implantable pacemakers.
- Company Name: St. Jude Heart Rhythm Management Co., Ltd.
- Publication Date: 2023-10-24
- Product Name: Pulse Generator implantable cardiac pacemaker
- Recall Level: Level 1 Recall
- Recall Reason: Certain models and batches of implantable cardiac pacemakers may have device malfunctions.
- Discovering Company: Abbott Medical (Shanghai) Co., Ltd.
- Manufacturing Company: St. Jude Heart Rhythm Management Co., Ltd.
- Summary: St. Jude Medical Cardiac Rhythm Management Division, in cooperation with Abbott Medical Products (Shanghai) Co., Ltd., has initiated a voluntary Class I recall of specific models and batches of its Pulse Generator implantable pacemakers. Reported to the National Medical Products Administration (NMPA) on October 24, 2023, this action stems from the potential for serious device malfunctions in these critical medical devices. The recall specifically targets implantable pacemakers identified by National Medical Device Registration Certificate 20183120455. A Class I designation signifies that there is a reasonable probability that the use of the product could cause serious adverse health consequences or death, underscoring the severity of the identified issues. Under the NMPA's regulatory oversight, the manufacturer is taking proactive measures to address these potential risks to patient safety. All stakeholders are advised to consult the accompanying "Medical Device Recall Event Report Form" for comprehensive details, including specific product identifiers and batch information, to ensure proper handling and mitigation of associated health risks.

Company: https://www.globalkeysolutions.net/companies/st-jude-heart-rhythm-management-co-ltd/2d5fd164-3862-41ef-b75f-600d2ab699be/