# China NMPA Product Recall - Arterial and venous catheterization

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/3809db93-874d-4375-bdfc-398cbbc21a0a/
Source feed: China

> China NMPA product recall for Arterial and venous catheterization by Medtronic Inc. published February 25, 2014. Recall level: . Medtronic, Inc. initiated a voluntary recall of its arterial and venous catheters on February 10, 20

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic, Inc. of the United States has recalled arteriovenous catheters.
- Company Name: Medtronic Inc.
- Publication Date: 2014-02-25
- Product Name: Arterial and venous catheterization
- Recall Reason: Medtronic has received reports of cannula dehiscence near the suture ring. The incidence rate is 0.06%. Potential patient harm from such dehiscence includes: • Inadequate blood flow, potentially leading to local ischemia or insufficient perfusion. • Difficulty inserting/removing the cannula tip, potentially causing surgical delay, vascular injury, dissection, or other complications that can be fatal.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic, Inc. initiated a voluntary recall of its arterial and venous catheters on February 10, 2014, after reports indicated cannula body cracking near the suture ring, occurring at an incidence rate of 0.06%. This critical issue posed risks of insufficient blood flow, potentially causing local ischemia or inadequate perfusion in patients. Additionally, difficulties encountered during catheter insertion or removal could lead to surgical delays, vascular injury, dissection, or other complications, which might be fatal. The National Medical Products Administration (NMPA) published this recall notice on February 25, 2014, having received a report from Medtronic (Shanghai) Management Co., Ltd. on February 14. The affected products, identified by CFDA (Imported) No. 20133665005, were intended for cardiopulmonary bypass surgery. Although the recall primarily impacted regions like the USA and Europe and no affected products were imported or sold in China, the NMPA directed all provincial and municipal food and drug administrations to enhance their supervision and management of related medical devices.

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