# 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/e960883b-3b79-409a-894d-ba0e549018c0/
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 March 16, 2021. Recall level: Level 2 Recall. Medtronic (Shanghai) Management Co., Ltd. announced a voluntary Class II recall for specific models 

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## 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: 2021-03-16
- Product Name: Implantable cardioverter-defibrillator (ICD); Implantable cardioverter-defibrillator (ICD); Implantable cardioverter-defibrillator (ICD)
- Recall Level: Level 2 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. announced a voluntary Class II recall for specific models of its Implantable Cardiac Resynchronization Therapy Defibrillators (ICD) and Implantable Resynchronization Therapy (IRPT) Cardioverter-Defibrillators (IDFs). This action, reported by the Shanghai Municipal Drug Administration under the National Medical Products Administration (NMPA) framework on March 16, 2021, addresses a performance issue identified through continuous monitoring and data modeling. The primary concern is that approximately 0.22% of devices containing Blackwell batteries, manufactured before July 2017, are exhibiting an earlier-than-expected 'recommended replacement time' warning. Furthermore, the period between this warning and the device's 'service termination' is shorter than anticipated, particularly affecting devices with low usage rates. While no permanent patient injuries or fatalities have been attributed to this issue, Medtronic is initiating the recall to address the potential malfunction. Affected products include models IRFTA 20193121539, IRFTA 20193121722, and IRFTA 20193121536, with comprehensive details available in the accompanying recall event report.

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