Abbott has recalled specific lots of its NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheters due to difficulty in removing the protective balloon sheath. This issue can cause problems in inflating or deflating the balloon, potentially leading to complications that include air embolism, additional intervention, thrombosis and myocardial infarction. According to an Abbott field safety notice, one reported case involving a balloon failure to deflate led to surgery, which caused post-operative complications and death.
The voluntary recall pertains to lots of the product that were manufactured between January 1, 2015 and January 2, 2017 and distributed between January 13, 2015 and March 14, 2017. It does not affect patients who have already undergone procedures using the devices.
Abbott issued the following statement regarding the recall: “Abbott began voluntarily recalling in March specific lots of three coronary catheters (NC TREK RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter). All customers have been notified to cease using the products and have confirmed to Abbott that the products are no longer in use. Abbott has already implemented corrective actions to ensure the products perform as intended. Products from the identified lots may exhibit difficulty in removing the protective balloon sheath, causing problems with inflating or deflating the balloon. The cumulative frequency of reported events in difficulty of removing the sheath and inflation and deflation of the balloon is 0.12 percent. This recall does not affect patients who have successfully undergone cardiac procedures using these devices.”