Abbott has instructed hospitals and healthcare professionals to immediately stop using some of its coronary catheters because of problems removing the balloon sheath, which may cause injury or death.
In a notice published Friday, the FDA deemed the action a class 1 recall, the most serious type of recall.
The devicemaker issued a field safety notice (PDF) on March 22 surrounding the NC Trek RX and NC Traveler RX coronary dilalation catheters, and the NC Tenku RX PTCA balloon catheter. Between them, the devices are indicated for dilating a coronary artery after a stent is implanted, as well as improving or restoring blood flow in coronary arteries via balloon dilation.
The notice affects devices manufactured between Jan. 1, 2015, and Jan. 2, 2017, and could affect as many as 449,661 devices. It does not affect patients who have successfully undergone treatment with the devices, the company said.
Physicians may experience difficulty removing the balloon sheath from the identified devices. If “excessive force” is used, it can cause problems inflating or deflating the balloon, Abbott wrote in the notice. This could lead to air embolism, or the blockage or a blood vessel by an air bubble, blood clots, heart attack or the need for additional intervention.
Abbott told customers to “immediately stop using the devices,” review their inventory and return all unused devices to the company. Abbott has also carried out corrective measures to make sure the devices work as intended, the company said. It is working with customers to replace the affected devices with a similar product.