# China NMPA Product Recall - Sherpa NX Guiding Catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/3b4d0a25-eb80-47bd-bcd3-74130b74f4a6
Source feed: China

> China NMPA product recall for Sherpa NX Guiding Catheter by Medtronic Inc. published June 24, 2019. Recall level: Level 2 Recall. Medtronic Inc., through its Medtronic (Shanghai) Management Co., Ltd. affiliate, has initiated a vol

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. is voluntarily recalling its Sherpa NX Guiding Catheter.
- Company Name: Medtronic Inc.
- Publication Date: 2019-06-24
- Product Name: Sherpa NX Guiding Catheter
- Recall Level: Level 2 Recall
- Recall Reason: The outermost layer of material is missing.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic Inc., through its Medtronic (Shanghai) Management Co., Ltd. affiliate, has initiated a voluntary Class II recall of its Sherpa NX Guiding Catheter (Registration Certificate No.: 20163771283). The recall was reported to the National Medical Products Administration (NMPA) on June 24, 2019, under NMPA Index No. JGXX-2019-10404. The primary issue prompting this action is a manufacturing defect involving the distal outer layer material of the affected product. This material problem poses a potential risk, leading to the proactive recall. The regulatory oversight for this recall falls under the jurisdiction of the National Medical Products Administration (NMPA) in China, which functions as the authoritative body for medical device regulation. The document explicitly identifies the recall as a Class II event, indicating a situation where the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Required actions involve the systematic retrieval of all affected Sherpa NX Guiding Catheters from the market. Specific details concerning the models, specifications, and batch numbers of the impacted devices are referenced in an accompanying 'Medical Device Recall Event Report Form,' though this attachment was not provided with the current document. Inspection dates were not specified within this recall notification.

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