According to Abbott, about one in one hundred (0.12% worldwide) of recalled NC Trek RX Coronary Dilatation Catheters and NC Traveler RX Coronary Dilatation Catheters have failed to deflate properly, putting patients at risk for prolonged cardiac ischemia, thrombosis, air embolism, myocardial infarction, and other serious complications.
Coronary dilation catheters are used in angioplasty procedures to open blocked vessels. Normally, they are inserted, inflated to break up the blockage, then deflated and removed. Abbott has received 13 reports of catheters failing to deflate. In one case, according to the FDA, "the inability to deflate the balloon necessitated intervention, which resulted in post-procedural complications leading to a patient death."
The problem is believed to have been the result of the catheters' excessive exposure to heat during the manufacturing process.
The affected products are NC Trek RX Coronary Dilatation Catheters and the NC Traveler Coronary Dilatation Catheters with balloon diameters of 4.0mm, 4.5mm and 5.0mm. They were manufactured between July 29 and December 19, 2019 and distributed between Aug. 16, 2019 and Jan. 3, 2020.
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