Teleflex announced on March 11 that it had voluntarily recalled the Arrow International intra-aortic balloon catheter kits and percutaneous insertion kits.
The company recalled 47,140 units distributed to hospitals, clinics and medical centers after finding out the sheath body may become separated from the sheath hub, which may lead to bleeding and interruption of or loss of intra-aortic balloon pump treatment.
Of the 13 adverse events reported, six serious injuries and one death occurred, according to Teleflex. The FDA classified it as a Class I recall, which the agency defines as "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
The Arrow intra-aortic balloon catheter kits and percutaneous insertion kits are inserted into the aorta to provide mechanical circulatory support for cardiac patients.