A recall has been issued for nearly 450,000 coronary catheters, due to a risk of problems removing the protective sheath, which may result in the need for immediate surgical intervention or death.
The Abbott coronary catheter recall was announced by the FDA on May 16, following a report that at least one patient undergoing a catheter removal required surgical intervention after the balloon failed to deflate. The patient suffered multiple post-surgical complications that lead to the patient’s death.
Following the report of the catheter removal complication, which lead to the patient’s death, Abbott issued an urgent field safety notice (PDF) to customers on March 22, stating that “[i]f excessive force is required to remove the balloon sheath, the sheath may damage the device causing problems with inflating or deflating the balloon.”
The initial field notice indicated that despite the isolated event, customers should quarantine and discontinue the use of certain NC Trek RX Coronary Dilation Catheters, NC Traveler Coronary Catheters and NC Tenku RX PTCA Balloon Catheters to prevent further injury.
Following an investigation into the fatality report, officials from Abbott determined that if the removal of the balloon sheath required excessive force, the device may become damaged and prevent the balloon from inflating or deflating. In this event, patients face several health risks; including air embolisms, thrombosis, myocardial infarction and surgical intervention that could lead to serious injury or death.
The FDA classified the notice as a Class I recall this week, indicating the problems with the use of the catheters carries a reasonable probability of serious injury or death for patients.
The catheter recall includes NC Trek RX Coronary Dilation Catheters, NC Traveler Coronary Catheters and NC Tenku RX PTCA Balloon Catheters manufactured by the Chicago, Illinois based Abbott Laboratories Pharmaceutical Company from January 1, 2015 through January 2, 2017.
According to the FDA, an estimated 449,661 units were distributed throughout the United States to medical professionals and healthcare providers from January 13, 2015 through March 14, 2017.
Abbott Laboratories began notifying recipients of the potentially affected recalled lots in March and is arranging the return and replacement of all remaining products. Customers with recalled products or those with questions are encouraged to contact Abbott Vascular Representative or Customer Service department on (800) 227-9902.
Repeated Catheter Safety Problems
Over the past year, millions of catheters have been recalled due to a variety of different problems, including a risk that tips and shafts may break or separate during use, posing severe adverse health consequences such as organ damage, stroke, kidney failure and intestinal failure, as well as death.
In July 2016, Stryker Sustainability Solutions announced a recall of its Angiodynamicsw Soft Vu Omni Flush Angigraphic Catheters in conjunction with the FDA due to tip separation risks.
In April 2016, Boston Scientific issued a Fetch Aspiration Catheter recall after reports that the shafts broke during procedures, posing embolism and clotting risks to patients. That recall came just a month after a recall of Arrow intra-Aortic Balloon Catheter kits, which was linked to at least one patient death due to a defect that caused the sheath body to be separated from the sheath hub.
The largest of the catheter recalls stemmed from Cook Medical, after 4.1 million Beacon Tip catheters were recalled in May 2016 that were distributed worldwide for tip separation problems. While no fatalities were reported in connection to that recall, there were several reports of the need for emergency removal procedures.