Abbott recently issued a voluntary recall for specific lots of three catheters due to difficulty in removing the protective balloon sheath, which may result in problems inflating or deflating the balloon.

Affected catheters include NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter, were manufactured between Jan. 1, 2015 – Jan. 2, 2017, and distributed from Jan. 13, 2015 – March 14, 2017.

Possible risks associated with balloon malfunctions include air embolism, additional intervention, thrombosis, myocardial infarction, and in one case, post–surgical complications resulting in death.

The total number of distributed units from identified lots potentially affected is 449,661. This recall does not affect patients who have successfully undergone cardiac procedures using these devices. Abbott has already implemented corrective actions to ensure the products perform as intended.