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Products liability news: Class I recall issued by Cook Medical

Cook Medical Inc. manufactures a device used primarily in patients suffering from a blunt traumatic aortic injury, here in Georgia and elsewhere. The company then received reports of adverse health consequences to patients in whom the Zenith Alpha Thoracic Endovascular Graft was implanted. The company could be facing significant products liability claims, especially since the Food and Drug Administration has labeled this recall as Class I.

A Class I recall indicates that the defective product could cause serious health ramifications, including death, to the patients implanted with the device. The function of the device is to treat lesions in the main blood vessel of a patient. This blood vessel supplies blood to the chest and abdomen from the heart.

The recall was issued because blood clots could form inside the device. In fact, the company has already received reports of this occurring. The device was closed or blocked, which put the affected patients' lives in danger.

The first notice the company sent to customers in March simply included a warning. A follow-up notice in June advised that the device should not be used for treating BTAI and that removing the appropriate devices that may be used to treat this condition from the market was the next step. In the meantime, numerous patients, some of whom may be here in Georgia, may require close observation.

Depending on what happens, products liability claims may be filed by patients, or their families in the event of death, if adverse health consequences occurred from the implantation of the defective product. Medical device manufacturers are supposed to ensure that the purposes for which their products are used will not jeopardize the health and safety of the patients using them. When that does not happen, it may be possible to seek restitution for the damages sustained.

Source: fda.gov, "Cook Medical Inc. Recalls Zenith Alpha Thoracic Endovascular Graft for the treatment of Blunt Traumatic Aortic Injury (BTAI) Due to the Potential Formation of Thrombus Inside the Device After Implantation", Accessed on Aug. 26, 2017

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