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.
