FDA: Abbott recalls coronary catheters

Editor's Note

The Food and Drug Administration on May 16 announced the recall by Abbott of specific lots of three coronary dilation and balloon catheters:

• NC Trek RX Coronary Dilation Catheter
• NC Traveler Coronary Dilation Catheter
• NC Tenku RX PTCA Balloon Catheter.

The affected lots were manufactured between January 2015 and January 2017.

The recall was initiated because of difficulty in removing the protective balloon sheath from the catheter, which could cause problems with inflating or deflating the balloon.

Risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction. In one patient, failure to deflate the balloon required surgery, which resulted in multiple postoperative complications leading to death.