The recall, which Abbott originally announced Jan. 29, involves nearly 14,000 NC Trek RX coronary dilatation catheters and NC Traveler RX coronary dilatation catheters with 4.0 mm, 4.5 mm and 5.0 mm balloon diameters. Abbott distributed the catheters August 2019 to January 2020.
Balloons from the impacted lots may not deflate as intended, according to FDA. The problem stems from weaker material close to the balloon bond that resulted from excessive exposure to heat during manufacturing.
Abbott has received 13 complaints related to the problem — as well as a report of one death.
Abbott’s Urgent Recall Notification instructed customers to immediately stop using and return the catheters included in the recall.
The company said in a statement shared with MassDevice: “Abbott has stopped shipping affected lots and has implemented corrective actions to ensure product performance moving forward.”