Abbott Vascular Recalls Three Coronary Catheters Because of Possible Sheath Removal Problems
Specific lots of three coronary catheters have been recalled by Abbott Vascular due to potential difficulty in removing the protective balloon sheath, an issue that has resulted in at least one patient death. The action has been designated as a Class I recall—the most serious—by the US Food and Drug Administration.
In an urgent field safety notice/device recall letter sent out in March, the company informed customers that certain lots of the NC Trek RX Coronary Dilatation Catheter, NC Traveler RX Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter may be affected by the sheath removal problem, which could cause problems with balloon inflation and deflation, ultimately resulting in air embolism, additional interventions, thrombosis, or MI.
One patient died from multiple complications following surgery that was required for a deflation failure.
Abbott Vascular said that the cumulative frequency of reported events related to difficulty in removing the sheath and inflation or deflation of the balloon is 0.12% worldwide and that all customers have confirmed that the affected products are no longer in use.
The recall involves 449,661 units from lots manufactured between January 1, 2015, and January 2, 2017 and distributed between January 13, 2015, and March 14, 2017. Additional details, including specific lot numbers, can be found here.
Abbott Vascular. Abbott initiates voluntary recall of specific lots of three coronary catheters. Published on: May 12, 2017. Accessed on: May 16, 2017.