FDA Update | Recall of Abbott NC Trek RX and NC Traveler RX Coronary Dilatation Catheters
Abbott Vascular is recalling the NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation Catheter, due to reports that the balloons from the impacted lots "may not deflate as intended" because of weaker material close to the balloon bond, resulting from excessive exposure to heat during manufacturing.
This recall impacts balloon diameters 4.0 mm, 4.5 mm and 5.0 mm.
The U.S. Food and Drug Administration has stated that use of these devices may cause "serious adverse health consequences, such as prolonged cardiac ischemia, air embolism, thrombosis, myocardial infarction and additional surgery that could lead to post-operative complications, including death."
Abbott Vascular has received 13 complaints related to this issue, with one death being reported.
Keywords: ACC Publications, Cardiology Magazine
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