Product Used in Thoracic Procedures Leads to Injury and Death
Global medical supply company Covidien has issued a voluntary recall of its Duet TRS Universal Straight and Articulating Single Use Loading Units. The Duet TRS is used by medical professionals when entering the thoracic (chest) cavity. The thoracic cavity contains the lungs, heart and various arteries and veins transporting blood to these organs and throughout the body.
The recall occurred after the company had received reports of 13 injuries and three deaths resulting from the application of the Duet TRS. The company admitted that the Duet TRS may injure anatomical structures within the thoracic cavity, including the heart and lungs. Not only will this result in complications after surgery, but it is potentially life-threatening. The product was being used on both adults and children.
There are 500,000 Duet TRS units worldwide and it has been sold since 2009. The recall was not instituted until customers received written notice of it by mail on January 12, 2012. The company estimates that about one-third of all Duet TRS units sold are being used for thoracic procedures.
Covidien insists that the Duet TRS is still usable in other contexts not involving the thoracic cavity, including abdominal surgeries. The company is making efforts to modify the instructions included with the device to clearly prohibit its use in the thoracic cavity for both adults and children. Along with other regulatory authorities across the globe, the Food and Drug Administration is assisting the company in changing the instructions. Covidien has also placed a hold on the Duet TRS in many countries so the product can be relabeled before it is used on any other patients.
Individuals who may have been injured by the Duet TRS device in a thoracic procedure may have a cause of action against Covidien. If you or someone you care about has been injured by the Duet TRS or another defective medical device, consider contacting a personal injury attorney who can help you determine your legal rights and recover for your injuries.