The company said it is recalling specific lots of the NC Trek RX coronary dilation catheter, the NC Traveler RX coronary dilation catheter and the NC Tenku RX PTCA balloon catheter over issues with removing the protective balloon sheath which can result in issues inflating or deflating the balloon.
Risks associated with inflation and deflation issues include air embolism, thrombosis, myocardial infarction and may require additional intervention. Abbott said. The company said it received 1 report of a case in which failure to deflate the balloon necessitated surgery, leading to multiple post-operative complications and death.
The recall affects a large number of part and lot numbers, supplied by Abbott in its press release, which was posted this week.
Abbott said that it has implemented corrective actions and instructed customers with the affected products to return them for replacement, pending availability.
The Chicago-area healthcare giant posted profits of $419 million, or 24¢ per share, on sales of $6.34 billion for the 3 months ended March 31, representing bottom-line growth of 32.6% on sales growth of 29.7% compared with Q1 2016.