THE ATTORNEYS AT SHOOP, A PROFESSIONAL LAW CORPORATION again warn of issues surrounding medical devices company Covidien. The manufacturer has issued a voluntary recall for all of its Duet TRS stapling heads, maintaining they should not be used in their "approved indication" - thoracic surgery - upon result of multiple injuries and death.
Covidien further admitted in a statement that the "Duet TRS has the potential to injure adjacent anatomical structures within the thorax, which may result in life-threatening, post-operative complications."
The various details of these injuries and related complications were undisclosed, yet the company is working presently in conjunction with with the United States FDA to change the use instructions regarding the the Duet TRS to reinforce that the device should not be used in thoracic procedures in adults and/or children.
Covidien has placed a voluntary "hold" on its Duet TRS inventory worldwide so it can relabel them with the new use instructions. The Duet TRS has been on the market for approximately two years, and Covidien has sold more than 500,000 units worldwide, the company stated.
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.