Medtronic Issues Class III Voluntary Recall of Evolut PRO+ Transcatheter Aortic Valve System Due to Regulatory Compliance Issues in Thailand

News on December 23, Medtronic (Shanghai) Management Co., Ltd. reported,Due to regulatory compliance issues in Thailand, the manufacturer Medtronic Inc. has voluntarily recalled its Transcatheter Aortic Valve System, Medtronic Evolut PRO+ System (Registration No. 20243130221 for Imported Medical Devices in China).。Recall level is Class III recall.

The products involved in this recall were not imported into China. For details such as specific models, specifications, and batches, please refer to the "Medical Device Recall Incident Report Form."

(Source: National Medical Products Administration)

It is reported that the recalled products were approved for marketing in China this April (Registration No.: 20243130221), and belong to Medtronic's fourth-generation interventional valve system.，Suitable for patients with aortic annulus diameters of 17*/18-30mm, its newly added 34mm valve size is the largest available on the market.

(Image source: Medtronic official website)

Previously, Medtronic had issued a notice regarding the safety of this product.The notice pointed out,When the valve stent folds inward along a vertical line, it appears as a seam, or the valve stent overlaps away from the inflow of the valve. Folding is different from insufficient valve expansion and may be detected during implantation or in the process of recapturing the heart valve.

Among them,Evolut Pro+ 34mm Has a Relatively High Incidence of Folding. FromOctober 1, 2019By August 31, 2022, the folding rate of Pro+34mm was 2.93%, of which 0.32% led to serious adverse events, including two deaths.Other serious events include unplanned surgeries for patients, such as surgical transplantation, valve replacement, aortic repair, implanting a new valve within the initial valve, which may also lead to aortic regurgitation/insufficiency, paravalvular leakage, hypotension, congestive heart failure, andAortic Dissection。

Medtronic was founded in 1949 and is headquartered in Minneapolis, Minnesota, USA. It is a global leader in medical technology. The company’s main product lines focus on four major businesses: cardiovascular, surgical and critical care, neuroscience, and diabetes. Its products and service systems cover treatment areas including arrhythmia, heart failure, cardiac intervention, heart valve replacement, diabetes, gastrointestinal diseases, urological diseases, spinal disorders, neurological diseases, and otolaryngology.

As a technology company, Medtronic is also committed to researching and developing new medical technologies to improve patients' quality of life. The company has numerous R&D centers and production bases worldwide, with a total workforce of over 90,000 employees. Medtronic's business spans more than 150 countries and regions globally.

On November 19, Medtronic announced its second-quarter (Q2) financial report for the period ending October 2024. From the perspective of revenue,Quarterly profit approaches 9.48 billion yuan, with sales reaching 280.2 billion yuan，Increased by 5.2% compared to the same period last year.Among which, the cardiovascular business revenueTo 22.6 billion yuan,Increased by 6.1%.