Abbott voluntarily recalls lots of three coronary catheters
The FDA announced that Abbott has initiated a voluntary recall of certain lots of three coronary catheters based on difficulty removing the protective balloon sheath, which could potentially lead to issues inflating or deflating the balloon.
According to a safety alert by agency, the problem could cause difficulty with inflation and deflation, which confers risks including air embolism, additional intervention, thrombosis and MI. In one case, the balloon’s failure to deflate led a patient to require surgery, and the surgery resulted in postoperative complications that led to death, the agency reported.
The balloon catheters (NC Trek RX Coronary Dilation Catheter, NC Traveler Coronary Dilation Catheter and NC Tenku RX PTCA) were manufactured between January 1, 2015 and January 2, 2017, and were distributed between January 13, 2015 and March 14, 2017, according to the alert.
As many as 449,661 units could be affected, but the recall does not apply to devices used in successful cardiac procedures, the FDA stated.
Abbott issued the following statement:
“All customers have been notified to cease using the products and have confirmed to Abbott that the products are no longer in use. Abbott has already implemented corrective actions to ensure the products perform as intended. Products from the identified lots may exhibit difficulty in removing the protective balloon sheath, causing problems with inflating or deflating the balloon. The cumulative frequency of reported events in difficulty of removing the sheath and inflation and deflation of the balloon is 0.12%. This recall does not affect patients who have successfully undergone cardiac procedures using these devices.”
The FDA is encouraging patients and professions to report adverse events or related side effects to MedWatch Safety Information and Adverse Event Reporting Program.
Reports can be filed at www.fda.gov/MedWatch/report.