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Abbott Recalls Malfunctioning Coronary Catheters That May Lead to Surgical Complications and Death

By Burg Simpson
May 17, 2017
2 min read

On May 16, 2017,  the U.S. Food and Drug Administration (FDA) announced that several lots of cardiac catheters manufactured by Abbott needed to be recalled due to the significant risk that the affected catheters may malfunction, possibly causing surgical complications and even death.

FDA Safety Alert Announcement

The affected lines of catheters include the NC Trek RX Coronary Dilation Catheter, the NC Traveler Coronary Dilation Catheter, and the NC Tenku RX PTCA Balloon Catheter.

These devices are supposed to operate by inflating a balloon within the coronary artery to assist in the placement of a stent or to help in restoring blood flow in patients with cardiac complications such as myocardial perfusions or heart attacks.  Unfortunately, Abbott reports that the affected lots of these devices may malfunction, causing problems inflating or deflating the balloon.

The medical complications associated with such malfunctions are significant and include the development of an air embolism, thrombosis, myocardial infarction, and the need for additional medical intervention.  Abbott reports that in one case, the failure of a balloon to deflate led to surgical intervention, post-surgical complications, and death.

If you or a loved one suffered injuries that you believe were caused by Abbott’s NC Trek RX Coronary Dilation Catheter, NC Traveler Coronary Dilation Catheter, or NC Tenku RX PTCA Balloon Catheter contact one of the experienced medical device attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.

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