Note that on January 16th, Covidien, a world wide provider of healthcare products, voluntarily recalled each production lot relative to its Duet TRS Universal Straight and Articulating Single Use Loading Units, with regard to its use with regard to procedures involving the thoracic cavity.
"After receiving reports connecting the use of the Duet TRS with patient deaths after thoracic surgery, we have made the decision that the product should not be used in such procedures," said Bryan Hanson, Group President, Surgical Solutions, Covidien. "Accordingly, we are advising our customers that the Duet TRS should not be used in thoracic surgery."
Covidien has presently received reports of thirteen (13) serious injuries and three (3) fatalities, secondary to the use and application of its Duet TRS in or about the thoracic cavity. The product defect associated with this medical device recall is that the Duet TRS has the potential to injure contiguous or adjacent anatomical structures or organs within the thorax, which may result in death or serious injury.
The affected product codes and descriptions are as follows:
- DUET6048ADUET TRS 45 3.5MM STRAIGHT SULU
- DUET TRS 45 3.5MM ARTICULATING SULU
Covidien has recalled these medical devices in conjunction with the United States Food and Drug Administration (FDA) for additional purposes of modifying use instructions to contraindicate the device in thoracic procedures in both adults and children.
As always, If you have suffered personal injury as a result of your use or interaction with a defective product (a product with a defective design, a product with manufacturing defects or defective warnings), you need experienced legal counsel with significant experience in product liability matters. Contact Shoop, A Professional Law Corporation today to speak with an experienced Los Angeles product liability attorney at (866) 884-1717.