FDA: Abbott Recalls NC Trek RX and NC Traveler Coronary Catheters

Abbott has voluntarily recalled specific lots of two coronary angioplasty catheters—the NC Trek RX coronary dilatation catheter and the NC Traveler coronary dilatation catheter—in three balloon diameters: 4.0, 4.5, and 5.0 mm.

The US Food and Drug Administration has classified the action as a Class I recall, its most serious category.

Affected products may deflate slowly, partially, or not at all, potentially causing “prolonged cardiac ischemia, air embolism, thrombosis, myocardial infarction, and additional intervention, such as surgery that could lead to postoperative complications which include death,” FDA’s MedWatch alert stated.

According to the manufacturer, the frequency of reported events is 0.12% worldwide, and at the time the field notice was issued, there had been no patient deaths. Since then, said the FDA, “Abbott has become aware of one reported case in which the inability to deflate the balloon necessitated intervention, which resulted in postprocedural complications leading to a patient death.”

The FDA action follows a Field Safety Notice, issued by Abbott on January 29, making hospitals and physicians aware of the affected lots—estimated at 40,429—that were distributed between August 16, 2019, and January 3, 2020. Any hospitals that have the defective products in stock are asked to stop using them immediately and return any that are unused to the company.

Providers are urged to read the field notice and report any problems to the manufacturer.