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.
If you or a loved one has been injured or killed by a faulty medical device, regardless of where you live in the United States, contact OnderLaw at 314-963-9000 for a free, no-obligation consultation. We are dedicated to holding companies accountable for putting patients at undue risk. We don't get paid unless you receive compensation.
OnderLaw, LLC in St. Louis has developed a solid reputation of excellence as a personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation, including Pradaxa, Lexapro and Yasmin/Yaz, Actos, Risperdal and others. The Onder Law Firm has won verdicts of more than $300 million in talcum powder ovarian cancer lawsuits, and has more experience representing Bayer/Monsanto glyphosate cancer victims than any other law firm in the country.