# China NMPA Product Recall - Disposable intracardiac mapping electrode catheter (trade name: Achieve)

Source: https://www.keypedia.com/records/china_product_recall/medtronic-ablation-frontiers-llc/9cc68619-3e94-4002-b6ea-80c6e4e7e2b2
Source feed: China

> China NMPA product recall for Disposable intracardiac mapping electrode catheter (trade name: Achieve) by Medtronic Ablation Frontiers LLC published December 10, 2015. Recall level: . The National Medical Products Administration (NMPA) announced a voluntary recall initiated by Medtro

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Navigation Inc. is recalling single-use cardiac mapping electrode catheters (trade name: Achieve).
- Company Name: Medtronic Ablation Frontiers LLC
- Publication Date: 2015-12-10
- Product Name: Disposable intracardiac mapping electrode catheter (trade name: Achieve)
- Recall Reason: The sterility of the product may have been compromised during shipment because a catheter connection intended for internal testing was inadvertently sent to the customer.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Ablation Frontiers LLC
- Summary: The National Medical Products Administration (NMPA) announced a voluntary recall initiated by Medtronic Navigation Inc. for its single-use cardiac mapping catheter, "Achieve" (Registration No.: CFDA (Imported) 2012 No. 3772886). Medtronic (Shanghai) Management Co., Ltd. reported on November 1, 2015, that the sterility of the disposable catheter connector (Model 990066, Batch U531) might have been compromised during shipment. As of September 28, 2015, two reports of sterility compromise were received, observed before product use. The root cause was identified as the inadvertent delivery of catheter connectors intended for internal testing to customers. Crucially, no adverse patient effects have been reported. Operating under the NMPA's regulatory framework (Index No. JGXX-2015-10260, published December 10, 2015), Medtronic is conducting an emergency medical device recall impacting 64 sets of the identified batch. The company confirmed that these affected products were not imported into or sold within China. Despite this, the NMPA has directed provincial and municipal food and drug administration departments to strengthen their supervision and management of similar medical devices.

Company: https://www.keypedia.com/companies/medtronic-ablation-frontiers-llc/15270aa8-7fea-404f-b85b-e32008a9949a