# China NMPA Product Recall - Drug-eluting coronary stent systems and rapid exchange coronary stent systems

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/414b6303-37a5-409e-8b99-09280cf891cd/
Source feed: China

> China NMPA product recall for Drug-eluting coronary stent systems and rapid exchange coronary stent systems by Medtronic Inc. published July 20, 2016. Recall level: . Medtronic Inc., supported by its Chinese entity Medtronic (Shanghai) Management Co., Ltd., initiated

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. is recalling its drug-eluting coronary stent systems and rapid exchange coronary stent systems.
- Company Name: Medtronic Inc.
- Publication Date: 2016-07-20
- Product Name: Drug-eluting coronary stent systems and rapid exchange coronary stent systems
- Recall Reason: Medtronic discovered unauthorized tampering with product packaging, particularly the use of counterfeit product labels, when receiving returned products from a distributor in Europe. Medtronic's investigation revealed that some products labeled as drug-eluting coronary stent systems actually contained fast-exchange coronary stent systems. Further investigation revealed that an external third-party distributor may have altered the outer labels of some products, resulting in inaccurate or incomplete information. However, the labels on the individual inner packages were unaffected. Although this incident does not affect product quality, Medtronic has decided to recall all drug-eluting and fast-exchange coronary stent systems shipped from its European distribution centers after March 29, 2016, due to the potential for incorrect labeling.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic Inc., supported by its Chinese entity Medtronic (Shanghai) Management Co., Ltd., initiated a voluntary recall of specific drug-eluting coronary stent systems and fast-exchange coronary stent systems, as documented by the National Medical Products Administration (NMPA) on July 20, 2016. The recall was prompted by the discovery of unauthorized tampering and the use of counterfeit outer packaging product labels by an unaffiliated third-party distributor in Europe. Investigations revealed instances where products were incorrectly labeled, for example, drug-eluting stents potentially packaged with fast-exchange stent labels. While the internal product labels remained correct, and Medtronic confirmed that the quality and safety of the devices were not compromised, the company decided to recall all affected products shipped from its European distribution centers after March 29, 2016. The recall primarily impacted regions like the Americas and Europe. Significantly, no affected products were sold or imported into China, rendering direct corrective actions by Medtronic within China unnecessary. The NMPA, however, requested provincial and autonomous region drug regulatory authorities to strengthen their supervision and management of similar products.

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