WASHINGTON, D.C. — Recently, the U.S. Food and Drug Administration (FDA) labeled the latest recall campaign from Abbot Vascular as a Class I recall. The Class I recall affects 13,891 dilation devices which Abbot Vascular distributed between August of 2019 and January of 2020. The two coronary catheters recalled were manufactured with a defect caused by excessive heat. The flaw could prevent the balloon from fully inflating during the catheter insertion procedure. According to Healio.com, the balloon failure could force the patient to undergo additional surgeries, endure air embolisms, myocardial infarction, and blood clots, that could end in death. Abbott Vascular advises its customers to stop using the recalled devices immediately to prevent harm to any patient.
Abbott Vascular issued the recall after receiving thirteen complaints of inflation problems. Additionally, one person reportedly died from complications caused by the defective dilation devices.
The FDA said that the weakened material close to the balloon, which happened during the manufacturing process as a result of exposure to excessive heat. The recalled dilation devices are Abbott Vascular’s NC Trek R and NC Traveler RX. Balloon diameters on the catheters include 4 mm, 4.5 mm, and 5 mm.
Abbott Vascular does not sell its NC Traveler RX in the United States because the FDA has not approved it for sale here. However, the NC Trek RX coronary catheter is used to help improve blood flow to the heart during cardiac events, including myocardial infarction. The device can also be used during in-stent implantation as well.
Abbott Vascular started notifying its customers on January 29, 2020, to stop using the devices immediately. Abbott Vascular is accepting returns of any unused products subject to the recall campaign. Abbott Vascular asked practitioners to share information to ensure that the recalled devices are not accidentally used on a patient. Abbott Vascular did not say how it has rectified the problem.
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