# China NMPA Product Recall - Implantable resynchronization therapy (RAPT) cardioverter defibrillator; Implantable resynchronization therapy (RAPT) cardioverter defibrillator; Implantable cardioverter defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-shanghai-management-co-ltd/5891aba7-3bc9-490e-bad3-96d55f6d0d47/
Source feed: China

> China NMPA product recall for Implantable resynchronization therapy (RAPT) cardioverter defibrillator; Implantable resynchronization therapy (RAPT) cardioverter defibrillator; Implantable cardioverter defibrillator by Medtronic (Shanghai) Management Co., Ltd. published October 27, 2020. Recall level: Level 2 Recall. Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall on October 27, 2020,

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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 (EDBs).
- Company Name: Medtronic (Shanghai) Management Co., Ltd.
- Publication Date: 2020-10-27
- Product Name: Implantable resynchronization therapy (RAPT) cardioverter defibrillator; Implantable resynchronization therapy (RAPT) cardioverter defibrillator; Implantable cardioverter defibrillator
- Recall Level: Level 2 Recall
- Recall Reason: Minor variations in raw materials from certain batches of batteries can cause programmers to display inaccurate lifetime estimates when programming implantable devices from specific batches. This poses a potential risk of unnecessary device implantation. The issue is that during the plateau phase of battery life, the estimated remaining voltage may be slightly lower than the standard discharge voltage, potentially leading to the programmer underestimating the remaining lifespan of the implantable device.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic (Shanghai) Management Co., Ltd.
- Summary: Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall on October 27, 2020, for specific batches of its implantable resynchronization therapy cardioverter-defibrillators and implantable cardioverter-defibrillators. This action, overseen by the National Medical Products Administration (NMPA), stemmed from manufacturing variations in battery raw materials within certain products. The primary issue is that the device's programmable controller may display inaccurate lifespan estimates during the stable phase of battery operation. While the actual battery performance and device functionality are not compromised, and critical indicators like the recommended replacement time remain accurate, the discrepancy could lead to an underestimation of the device's remaining lifespan. The main concern is the potential for unnecessary device implantation driven by these erroneous projections. Medtronic is taking required actions to recall the affected devices and has provided detailed information on the impacted models and batches, aiming to prevent premature replacements and ensure patient confidence.

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