Tracheostomy Tube Recall Lawsuits: Problems Reports of Breathing Problems, Serious Injuries

Harvey Kirk

By Harvey Kirk
Posted June 29, 2015

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Following a tracheostomy tube recall issued last week, the lawyers at Saiontz & Kirk, P.A. are reviewing potential product liability lawsuits for individuals who have experienced severe and potentially life-threatening injuries since November 2012 that may have been caused by design or manufacturing problems.

At least 12 confirmed serious injury reports have been linked to Shiley tracheostomy tubes, which appear to have been formed with a wider angle bend than models manufactured before November 29, 2012. The tracheostomy tube problems may result in severe pain, discomfort or potentially life-threatening breathing troubles.

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Tracheostomy tubes are placed through a patient’s windpipe during tracheostomy procedures, providing the patient with an airway that allows them to breath. However, multiple different types of Shiley tracheostomy tubes sold by Medtronic’s Covidien unit may contain dangerous defects, including: Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube Long Cuffless, Shiley Neonatal Tracheostomy Tube with TaperGuard Cuff, Shiley Pediatric Tracheostomy Tube with TaperGuard Cuff, Shiley Pediatric Tracheostomy Tube Long with TaperGuard Cuff, Shiley Neonatal Tracheostomy Tube Cuffless, Disposable Bedside Tray, and Pediatric Tracheostomy Tube Cuffless, Disposable Bedside Tray.

According to a press release issued by Medtronic last week, at least a dozen serious injury reports have been identified by the manufacturer, which may represent only a small fraction of the tracheostomy tube complications actually experienced at hospitals nationwide. These include reports of patients experiencing breathing difficulties that impacted oxygen levels immediately upon tube placement or discomfort.

The manufacturer indicates that replacement of the tracheostomy tubes with devices manufactured before November 2012 seemed to address the problem, suggesting a design defect or manufacturing issue that may have impacted tracheostomy tubes used in recent years.

Tracheostomy Tube Recall Lawyers

Medtronic first notified hospitals and distributors that there was a problem on May 8. In the notification, the medical device manufacturer requested that all its customers and distributors check their inventory for the recalled tubes, discontinue use and quarantine all affected devices.

The lawyers at Saiontz & Kirk, P.A. are reviewing whether individuals who have experienced complications or an injury may be entitled to financial compensation through a tracheostomy tube lawsuit. To submit information about tracheostomy tube problems suffered by yourself or a loved one, request a free consultation and claim evaluation.

1 Comment • Add Your Comments

  • Roseann says:

    Good afternoon my name is Ms roseann clark I went online to see if there has ever been a report on recall on tracheostomy my son had tracheostomy surgery back in January of 2020 was back and forth with my son to emergency room he was diagnosed with new-monia plus he was a quadrilateral he passed away in April 2020 just wanted to know if there has ever been a recall on tracheostomy I read it calls injury even death he was age 32 year’s old thank you

    Posted on July 14, 2021 at 3:17 pm

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