FDA designates recall of two coronary dilatation catheters as class 1
The FDA has designated Abbott Vascular’s product recall of two coronary dilatation catheters as a class 1 recall, the most serious kind. The recall affects 13,891 devices distributed between August and January.
Weak material close to the balloon bond as a result of excessive heat exposure during the manufacturing process may lead to balloon inflation failure of the two coronary dilatation catheters (NC Trek RX, NC Traveler RX) with balloon diameters of 4 mm, 4.5 mm and 5 mm, according to a MedWatch report from the FDA. This may result in health consequences including air embolism, prolonged cardiac ischemia, MI, thrombosis and additional surgery that may lead to complications after the procedure, including death.
The NC Trek RX coronary dilatation catheter is currently indicated for use in CABG to improve myocardial perfusion, to restore coronary flow in patients with MI and in stent implantation, according to the report. The NC Traveler RX has not been cleared for commercial distribution in the United States.
The company has received 13 complaints associated with this issue in addition to a report of one death.
Abbott Vascular distributed an urgent recall notification to customers on Jan. 29 alerting them to stop using the devices immediately, return unused affected products and to share the information with other personnel, according to the report.