# China NMPA Product Recall - guiding catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/2bebaa42-108c-4855-b45a-30df9abf887e/
Source feed: China

> China NMPA product recall for guiding catheter by Medtronic Inc. published November 23, 2017. Recall level: Level 2 Recall. Medtronic Inc. initiated a Class II voluntary recall of specific batches of its 6F Taiga guiding cat

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. voluntarily recalls guidance tubes
- Company Name: Medtronic Inc.
- Publication Date: 2017-11-23
- Product Name: guiding catheter
- Recall Level: Level 2 Recall
- Recall Reason: Medtronic is voluntarily recalling specific batches of its 6F Taiga guiding catheters because, as of September 19, 2017, it had received eight reports of tip detachment or tearing during in vivo use. No deaths related to this issue have been reported. Potential patient risks associated with tip detachment or tearing include unintended medical intervention, stroke, occlusion, embolism, perforation, and anatomical complications. Medtronic has identified specific batches of 6F Taiga guiding catheters manufactured between June 2, 2016, and May 9, 2017, as affected by this issue; other products are unaffected.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic Inc. initiated a Class II voluntary recall of specific batches of its 6F Taiga guiding catheters, as reported by Medtronic (Shanghai) Management Co., Ltd. to the National Medical Products Administration (NMPA) in October 2017. The recall stems from eight reports received by September 19, 2017, detailing potential tip detachment or cracking of the catheters during in vivo use. These issues could lead to serious patient risks, including unintended medical intervention, stroke, occlusion, embolism, perforation, and dissection, although no related deaths were reported. The affected guiding catheters were manufactured between June 2, 2016, and May 9, 2017. Medtronic identified these batches as subject to the issue. Notably, the corrective action clarifies that while this is a serious recall, the specific affected products were not sold within China, impacting other regions like Japan. This NMPA document serves as the regulatory filing in China for a global corrective action initiated by Medtronic to address the identified product safety concern.

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