Arrow International has initiated a worldwide voluntary recall of 5800 Series Intra-Aortic Balloon Catheters (IAB) with Super Arrow-Flex Sheath Introducers, due to problems with the sheath introducers.
Arrow said the recall has been initiated by the company due to the increase in complaints in which the IAB was stuck in the sheath
When the IAB is stuck in the sheath, the user would be unable to move the IAB catheter forward or backward, potentially leading to a delay in critical therapy.
Excessive manipulation of the IAB as a result of it being stuck in the sheath during insertion may lead to excessive bleeding or arterial damage, significant vasospasm, prolonged tissue ischemia, tissue/vascular ischemia, injury, infarct, or death.
The US Food and Drug Administration has classified this action as a Class I recall, which is issued a reasonable probability that the use of a violative product will cause serious adverse health consequences or death.
Healthcare facilities are recommended to immediately discontinue use of the device and return all unused 5800 Series IABs with Super Arrow-Flex Sheath Introducers to Arrow.