# China NMPA Product Recall - Implantable cardioverter-defibrillator (ICD); Implantable cardioverter-defibrillator (ICD); Implantable cardioverter-defibrillator (ICD)

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-shanghai-management-co-ltd/ffcf3202-cb02-4423-8716-6fa30a71e8e7/
Source feed: China

> China NMPA product recall for Implantable cardioverter-defibrillator (ICD); Implantable cardioverter-defibrillator (ICD); Implantable cardioverter-defibrillator (ICD) by Medtronic (Shanghai) Management Co., Ltd. published April 16, 2021. Recall level: Level 1 Recall. Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class 1 recall on April 16, 2021, fo

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic (Shanghai) Management Co., Ltd. is voluntarily recalling implantable resynchronization therapy (IRPT) cardioverter-defibrillators (ICDs).
- Company Name: Medtronic (Shanghai) Management Co., Ltd.
- Publication Date: 2021-04-16
- Product Name: Implantable cardioverter-defibrillator (ICD); Implantable cardioverter-defibrillator (ICD); Implantable cardioverter-defibrillator (ICD)
- Recall Level: Level 1 Recall
- Recall Reason: Due to the lithium plating process of lithium batteries, approximately 0.22% of devices containing Blackwell batteries manufactured before July 2017 will display a "recommended replacement time" warning earlier than expected, and the time between the "recommended replacement time" and "service termination" will be shorter. Devices with low usage rates are more likely to experience this warning, while devices with high usage rates are less likely to malfunction.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic (Shanghai) Management Co., Ltd.
- Summary: Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class 1 recall on April 16, 2021, for specific implantable cardiac resynchronization therapy defibrillators (ICD). This action, overseen by the National Medical Products Administration (NMPA) and announced by the Shanghai Municipal Drug Administration, addresses a manufacturing issue identified through continuous monitoring. The primary concern is that approximately 0.22% of devices containing Blackwell batteries, manufactured before July 2017, may prematurely display a "recommended replacement time" warning. This issue shortens the interval between the initial warning and the device's "service termination," making it more prevalent in devices with low usage rates. While no permanent patient injuries or fatalities have been reported due to this anomaly, the company is undertaking this recall to ensure patient safety and device reliability. The specific affected models, specifications, and batches are detailed in the accompanying Medical Device Recall Event Report Form, requiring professional adherence to the recall instructions for affected products.

Company: https://www.globalkeysolutions.net/companies/medtronic-shanghai-management-co-ltd/e5ba243d-a47a-4442-84d4-1e11f92f75e2/