Abbott Labs Recalls Some Catheters Due to Possible Defects
The U.S. Food and Drug Administration stated on Wednesday that some lots of two catheters models sold by Abbott Laboratories (NYSE: ABT) needed to be recalled due to potentially severe safety issues. The agency defined them as Class I recalls, the most serious type, and it warned that using these devices could cause serious injury or even death.
The models in question are the NC Trek RX and the NC Traveler RX coronary dilation catheters with balloon diameters of 4.0mm, 4.5mm, and 5.0mm. The issue is that the balloons may not deflate the way they are supposed to. The problem seems to have been caused by overexposure to heat during the manufacturing process, which weakens the material near the balloon.
Image source: Getty Images.
Source Fool.com
