Abbott Vascular Pulling Catheters from Market after Reported Death
Surgeons performing heart procedures often rely on what are called “coronary dilatation catheters” to open clogged blood vessels and improve blood flow to the heart. The catheters are supposed to operate by inflating a balloon within the coronary artery. The balloon’s expansion allows a surgeon to place a stent and restores blood flow in a patient suffering from heart complications.
If the devices do not perform as intended, the results can be tragic. For example, if the catheter’s balloon fails to inflate or deflate, a patient could suffer from reduced blood flow to the heart, a blood clot, a heart attack, and even death. These significant dangers make Abbott Vascular’s recent recall of its catheters especially concerning.
On January 29, 2020, Abbott Vascular announced that it is recalling several lots of its NC Trek RX and NC Traveler RX coronary dilatation catheters due to reports of their balloons not deflating as intended. According to the FDA’s announcement, the recalled lots were overexposed to heat during the manufacturing process. The excess heat weakened the material close to where the balloon bonds to the guiding tube, and has led to issues with the balloon deflating. The FDA warns that use of the recalled catheters could result in a prolonged or additional surgery, reduced blood flow to the heart, a blood clot, a heart attack, and even death. Tragically, the firm is aware of at least one death involving the devices.
If you or a loved one has suffered injuries during a heart operation that you suspect were caused by an Abbott Vascular coronary dilatation catheter, contact one of the experienced medical device attorneys at Burg Simpson’s Cincinnati office today. Our accomplished team of lawyers possesses the skills and resources to investigate your potential claim and fight for the money you deserve. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.
(Burg Simpson previously wrote on a 2017 recall involving Abbott’s NC Trex RX and NC Traveler Coronary Dilation Catheter here.)