February 24, 2020 — Abbott has voluntarily recalled specific lots of two types of its coronary angioplasty catheters — the NC Trek RX Coronary Dilatation Catheter and the NC Traveler Coronary Dilatation Catheter. The balloons from the impacted lots may not deflate as intended. The U.S. Food and Drug Administration (FDA) has classified this as a Class I recall.
Potential risks of the balloons not deflating include prolonged cardiac ischemia, air embolism, thrombosis, myocardial infarction and additional intervention, such as surgery that could lead to post-operative complications, which include death.
The FDA has classified this as a Class I recall. The recalls includes balloon diameters 4 mm, 4.5 mm and 5 mm. The FDA said this recall does not affect patients who have successfully undergone cardiac procedures using these devices.
Abbott issued a field safety notice (FSN) Jan. 29, 2020, to physicians and hospitals who received coronary catheters from the affected lots. The company is arranging the return and replacement of all remaining products. The affected products were manufactured between July 29, 2019, through Dec. 19, 2019, and distributed between Aug. 16, 2019, and Jan. 3, 2020. The total number of distributed units from identified lots potentially affected is 40,429.
The frequency of reported events that include slow, partial and failure to deflate the balloon, is 0.12 percent worldwide. At the time the FSN was issued, there were no reports of patient death. Since the issuance of the FSN, Abbott has become aware of one reported case in which the inability to deflate the balloon necessitated intervention, which resulted in post-procedural complications leading to a patient death.
Healthcare providers that received the Jan. 29, 2020 FSN directed to read the document and follow its instructions.