In a March 22 letter to customers, Abbot said the recall affects its NC Trek RX and NC Traveler RX coronary dilatation catheters and the NC Tenku RX PTCA balloon catheter.
“Product from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon,” Abbott said. “If excessive force is required to remove the balloon sheath, the sheath may damage the device causing problems with inflating or deflating the balloon.”
The potential risks include air embolism, additional intervention, thrombosis and myocardial infarction. The problem, reported in just 0.12% of cases worldwide, required surgery in 1 case that led to “multiple post-operative complications and death,” the Chicago-area medtech giant said. The recall does not affect patients who have already had procedures using the devices, Abbott said.
An Abbott spokeswoman told MassDevice.com via email that all customers who received the affected devices have confirmed that they’re no longer using them.
“Abbott has already implemented corrective actions to ensure the products perform as intended,” she wrote.
The FDA gave the voluntary recall Class I status, denoting the risk of serious injury or death. The catheters were made between January 2015 and January of this year and sold between January 2015 and March.