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Covidien Duet TRS Recall Lawsuit Attorney

Covidien Duet TRS Side Effects Recall Lawsuit Attorney

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Covidien Duet TRS Side Effects Lawsuit

Covidien has voluntarily recalled cartridges of tissue-reinforcing staples intended for endoscopic thoracic surgery after receiving reports of 3 deaths and 13 serious injuries associated with their use in the thoracic cavity (chest cavity), the company announced yesterday.

Covidien is also contraindicating the use of the cartridges, called Duet TRS universal straight and Duet TRS articulating single-use loading units, for thoracic surgery. Covidien has concluded that Duet TRS has the potential to injure adjacent anatomical structures within the thorax, which may result in life-threatening, post-operative complications.

The recall and the contraindication do not apply to cartridges intended for laparoscopic surgeries in other indicated parts of the body, such as the abdomen. The company said that it believes that roughly one third of global procedures relying on the Duet TRS stapling and tissue-reinforcement technology are for thoracic indications. It said it has sold more than 500,000 units since the product's debut in 2009.

The Duet TRS staple cartridge, which is the business end of a reloadable surgical stapling gun, contains bands of a synthetic tissue-reinforcement material in addition to the staples themselves. Duet TRS Reload is a Single Use Loading Unit that is preloaded with a fully integrated tissue reinforcement material offering surgeons the option of adding tissue reinforcement to endostapling without any additional steps. The company said it is providing customers with information on alternative tissue-reinforcement products that may be safely used with its endoscopic staplers for thoracic surgery.

The recall applies to the following 8 versions of the cartridge:

  • DUET4535,
  • DUET4535A,
  • DUET4548,
  • DUET4548A,
  • DUET6035,
  • DUET6035A,
  • DUET6048, and
  • DUET6048A.

In September 2011, the FDA announced a class 2 recall of the same 8 versions of the Duet TRS cartridge because a breach in its packaging compromised the product's sterility.

Serious Side Effects of Covidien Duet TRS

Covidien has received reports of 13 serious Duet TRS injuries and three Duet TRS fatalities, following the application of Duet TRS in the thoracic cavity. The Company has concluded that Duet TRS has the potential to injure adjacent anatomical structures within the thorax, which may result in life-threatening, post-operative complications. Covidien has not specified which types of injuries or complications the Duet TRS could cause within the throacic cavity so one can only speculate.

The thoracic cavity, which is also called the chest cavity,  is the second largest hollow space of the body. It is enclosed by the ribs, the vertebral column, and the sternum, or breastbone, and is separated from the abdominal cavity (the body’s largest hollow space) by a muscular and membranous partition, the diaphragm. It contains the lungs, the middle and lower airways - the tracheobronchial tree - the heart, the vessels transporting blood between the heart and the lungs, the great arteries bringing blood from the heart out into general circulation, and the major veins into which the blood is collected for transport back to the heart.

Coviden Duet TRS Recall Lawsuit News Archive::

Thoratic Cavity - Chest Cavity - Heart - Lungs

If you or a loved one have suffered serious side effects of the Covidien Duet TRS, Covidien Duet TRS injury or death while using the Covidien Duet TRS you may be entitled to compensation. Contact the Covidien Duet TRS side effects lawyers of Ennis & Ennis, P.A. today for a free nationwide case evaluation. Our experienced Covidien Duet TRS attorneys can answer any questions you may have about Covidien Duet TRS side effects or a potential Covidien Duet TRS lawsuit. Fill out the case evaluation form on this page or call toll free: 1.800.856.6405.

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Ennis & Ennis, P.A. is currently handling cases for the following Covidien Duet TRS Injuries:

 

Thoratic Cavity Injury

Heart Injury

Lung Injury

Internal Bleeding

Death

If you or a loved one have suffered serious Covidien Duet TRS side effects, injury or death while using Covidien Duet TRS you may be entitled to compensation. Contact the Covidien Duet TRS side effects Attorneys of Ennis & Ennis, P.A. today for a free nationwide case evaluation. Our experienced Covidien Duet TRS attorneys can answer any questions you may have about Covidien Duet TRS chest cavity injury or a potential Covidien Duet TRS lawsuit. Fill out the case evaluation form on this page or call toll free: 1.800.856.6405.
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