The FDA announced on February 20, 2020 that Abbott has voluntarily recalled specific lots of two catheters used in coronary angioplasty procedures: the NC Trek RX Coronary Dilatation Catheter and the NC Traveler Coronary Dilatation Catheter, balloon diameters 4.0mm, 4.5mm and 5.0mm. The recall does not affect patients who have successfully undergone cardiac procedures using these devices.
Abbott issued a Field Safety Notice (FSN) External Link Disclaimer on January 29, 2020 to physicians and hospitals who received coronary catheters from the affected lots and is arranging the return and replacement of all remaining products. The affected products were manufactured between July 29, 2019 and December 19, 2019, and distributed between August 16, 2019 and January 3, 2020. The total number of distributed units from identified lots potentially affected is 40,429.
Coronary Dilation Catheters
Coronary dilation catheters are used to open clogged blood vessels to improve blood flow to the heart. The balloons from the impacted lots may not deflate as intended. Potential risks 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 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.
Abbott’s Coronary Dilatation Catheters are indicated for use in the following cardiac procedures:
– balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving blood flow to the heart;
– balloon dilatation of a coronary artery occlusion (blocked or clogged artery), for the purpose of restoring coronary blood flow in patients with ST-segment elevation myocardial infarction (heart attack); and
– balloon dilatation of a stent after implantation (2.00 mm – 5.00 mm balloon models only).
Abbott initiated the voluntary recall of specific lots of the catheters due to 19 reports of injury, and 1 report of death associated with difficulty removing the protective balloon sheath, resulting in issues with inflating or deflating the balloon.
Abbott is recalling products from the identified lots because physicians may experience difficulty in removing the protective balloon sheath. This can result in issues with inflating or deflating the balloon during procedures and may cause serious adverse health consequences including: air embolism, thrombosis (clot in the artery), myocardial infarction (heart attack), and death.
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