The federal watchdog agency said it received 25 complaints, but no reports of injuries, about a problem it described as a faulty volume connection for the Everett-based company’s 30cc, 40cc and 50cc Intra Aortic Balloon Pump catheters made by its Arrow International subsidiary.
A Class 1 recall means the FDA believes there’s “reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death,” according to an agency press release:
“This recall is being conducted because a fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5cc or 5cc, rather than the appropriate 30, 40, or 50cc volume. In patients exhibiting moderate to severe myocardial ischemia or low perfusion states, prolonged exposure to the low default volume may fail to decrease ischemia and increase perfusion, leading to organ injury or infarct and may result in patient death. Prolonged exposure to a device which is inflated to less than 2/3 full could also result in thrombus formation on the IAB and possible subsequent systemic or cerebral thromboembolism.”
Teleflex first issued a voluntary recall of the product Feb. 2, followed by the FDA action announced today.