The US Food and Drug Administration (FDA) has classified this as a Class I recall, where exposure to a device presents a reasonable likelihood of serious adverse health consequences or death. The recall was prompted by reports that the catheters may exhibit difficulty in removing the protective balloon sheath, which could cause problems with inflating or deflating the balloon.
Potential risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction. In one reported case, failure to deflate the balloon necessitated surgery, which resulted in multiple post-surgical complications leading to death.
The total number of distributed units from identified lots potentially affected is 449,661. Abbott has initiated the recall for specific lots of the three catheters that were manufactured between January 1, 2015 and January 2, 2017, and were distributed between January 13, 2015 and March 14, 2017.
Catheters are used for many reasons, including the administration of medications, injecting contrast dye for angiogram procedures, or removing small blood clots (thrombectomy) from veins and arteries. These devices are inserted into a blood vessel through a small puncture made in skin. Makers of these devices have issued multiple urgent safety recalls for millions of these devices due to reports that the devices are breaking and migrating.