In March this year, the official website of the Shanghai Municipal Drug Administration released information stating that Covidien Global received customer reports claiming,A batch of tracheostomy cannulas had an issue where the fixation wings detached from the outer cannula. As a result, the company initiated a voluntary recall of the tracheostomy cannulas (Registration No.: Guo Xie Zhu Jin 20172085250). The recall level is Class I.

The number of recalls in China is 35, and no patient injury complaints or adverse events related to this issue have been received in China.

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Medtronic Recalls Nearly 600,000 Products in Class I Recall

The FDA announcement shows that Medtronic has notified all affected customers of this issue and sent an urgent recall notice in February.

FDA further added: "The use of devices with flanges disconnected from the device cannula may lead to respiratory failure, airway tissue damage, suffocation (aspiration), respiratory infections, airway tightening (bronchospasm), treatment delays, and/or death.Medtronic has not reported any serious injuries or deaths related to this issue.”

The Unique Device Identifier (UDI) of this product: A8845212054401, 20884521205441, 10884521205444

Lot/Serial Number:Lot:202405258X，SKU/CFN：7CN80R

The above product is used to assist patients in breathing by providing tracheal access. It can be used during percutaneous dilatational tracheostomy (PDT) – a surgical procedure that creates an opening in the neck to place a tube.

Nearly 600,000ProductClass I Recall

Shiley belongs toMedtronicAcute Care & Monitoring——The acute care and monitoring business is a classic airway management brand that originated in 1970. It was researched, developed, and designed over three years by Mr. Donald Shiley and Dr. Kenneth Hardy. More than 760 million tracheostomy tubes have been used worldwide.

According to the introduction, the Shiley tracheostomy tube series launched in 2015 and later was fully upgraded to the Shiley Flex Soft Tracheostomy Family, including two series: tracheostomy tubes with reusable inner cannulas (with tapered cuffs / cuffless) and tracheostomy tubes with disposable inner cannulas (with tapered cuffs / cuffless), offering a better fit, more comfort, and greater convenience.

Shiley is one of the few brands in China that provides tracheostomy solutions for newborns and pediatric patients, including various models and sizes that better fit the anatomical structure of young patients. It also utilizes Medtronic's patented taper-shaped cuff technology, which helps protect the patient’s airway.

Medtronic CEO Geoff Martha said,Funds saved from shutting down the ventilator business will increase investment in the new division (ACM), particularly in remote patient monitoring.

Currently, MedtronicUnder ACMThe two largest brands are the Nellcor pulse oximeter and Shiley endotracheal tubes.

Company 2025 (As of April 25, 2025)) The financial report shows,Annual revenue of 33.6 billion yuanUSD, with an organic growth of 4.9%;Q4 revenue of $3.34 billion, with organic growth of 7.8%.

Medical Surgical BusinessAnnual RevenueRanked third among the four major businesses, with $8.41 billion, representing an organic growth of 0.8%; Q4 revenue reached $2.21 billion, marking an organic growth of 2.0%.。

The ACM business under it achieved a full-year revenue of 1.91 billion U.S. dollars, with an organic growth of 0.8%; the fourth-quarter revenue was 500 million U.S. dollars, with an organic growth of 3.1%.

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Since Medtronic abandoned the split of the entirePMRI, Restructuring InsteadFollowing the ACM business, the market performance of this division has been closely watched. At the time, it was rumored that the main reason Medtronic retained the ACM business could be that patient monitoring devices, pulse oximeters, and telemedicine platforms generate a large amount of patient data, reaching approximately 100 million patients annually, which is highly significant for intelligent care. Can Medtronic realize this vision in the future? Medical Device News will continue to monitor.