# China NMPA Product Recall - Single-use radiofrequency ablation electrode catheters (Sterile Electrode Catheters for Intracardiac Ablation)

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/10644074-c346-4c64-8442-5cbc305a9f42/
Source feed: China

> China NMPA product recall for Single-use radiofrequency ablation electrode catheters (Sterile Electrode Catheters for Intracardiac Ablation) by Medtronic Inc. published August 06, 2019. Recall level: Level 3 Recall. On August 6, 2019, the National Medical Products Administration (NMPA) published a recall notice (In

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic, Inc. is voluntarily recalling its single-use radiofrequency ablation electrode catheters (RF).
- Company Name: Medtronic Inc.
- Publication Date: 2019-08-06
- Product Name: Single-use radiofrequency ablation electrode catheters (Sterile Electrode Catheters for Intracardiac Ablation)
- Recall Level: Level 3 Recall
- Recall Reason: The issue involves some product models not listed in the registration certificate.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: On August 6, 2019, the National Medical Products Administration (NMPA) published a recall notice (Index No. JGXX-2019-10502) concerning a voluntary recall by Medtronic, Inc. The recall, reported by Medtronic (Shanghai) Management Co., Ltd., involves specific models of their single-use radiofrequency ablation electrode catheters for intracardiac ablation (RF), operating under Registration Certificate No.: 20153213975. The core issue prompting this Class III recall is that certain product models were not accurately listed on the registration certificate. This indicates an administrative non-compliance with regulatory listing requirements rather than an identified product performance or safety defect. As a required action, Medtronic, Inc. is initiating a voluntary recall of the affected catheters. Detailed information on the specific models, specifications, and batches involved is provided in the associated "Recall Event Report Form" attachment, reinforcing the NMPA's regulatory framework for ensuring medical device adherence to registration standards.

Company: https://www.globalkeysolutions.net/companies/medtronic-inc/398d5f72-c7d2-4c97-94fc-fbef4cf2336d/