Abbott Issues Recall For Coronary Catheters Due to Difficulty Removing Balloon Sheath
Abbott recently issued a voluntary recall for specific lots of three catheters due to difficulty in removing the protective balloon sheath, which may result in problems inflating or deflating the balloon. Affected catheters include NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter, were manufactured between Jan. 1, 2015 – Jan. 2, 2017, and distributed from Jan. 13, 2015 – March 14, 2017. Possible risks associated with balloon malfunctions include air embolism, additional intervention, thrombosis, myocardial infarction, and in one case, post-surgical complications resulting in death. The recall does not apply to patients who have successfully undergone cardiac surgery with these devices, and distributed units from the identified lots total 449,661. Read the full announcement from the U.S. Food and Drug Administration here.
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