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Abbott Coronary Catheters Recalled for Deflation Problems

NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation Catheters have caused one death so far.

Thursday, March 12, 2020 - Abbott has issued a voluntary recall of over 40,000 cardiac dilation catheters after several reports and one patient death. The FDA has designated this recall as a Class 1 recall, which is the most serious type due to the device's potential to cause death.

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.

Affected lot numbers can be found here.

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 1-800-RxWatch 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.

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