Medtronic Inc. Recalls HawkOne Directional Atherectomy System

The United States Food and Drug Administration (FDA) has issued the following important notice:

Medtronic Inc. Recalls HawkOne Directional Atherectomy System Due to Risk of Tip Damage During Use. Medtronic Inc. is recalling this product due to the risk of the tip of the catheter becoming damaged during use, which may include the catheter tip breaking off or separating. If this occurs, this could lead to serious adverse events such as a tear along the inside wall of an artery (arterial dissection), a rupture or breakage of an artery (arterial rupture), decrease in blood flow to a part of the body because of a blocked artery (ischemia), and/or blood vessel complications that could require surgical repair and additional procedures to capture and remove the detached and/or migrated (embolized) tip. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.  

Where a defective product causes serious injury or death, a “products liability” case can be brought to recover full and fair compensation. Mr. Smith has experience in both the prosecution and defense of such cases.

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