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May 22, 2017
3 Min Read
One patient has died and 19 were injured by coronary dilation catheters, FDA said.
Abbott's NC Trek RX Coronary Dilatation Catheter is among the devices impacted by the company's recall.
Abbott is recalling 132,040 coronary dilation catheters for issues with inflating or deflating the balloon within the protective sheath.
The recalled devices are in specific lots of Abbott Vascular's NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and/or NC Tenku RX PTCA Balloon Catheter, according to FDA and the company. They were manufactured between January 2015 and January 2017, and distributed through March 14, 2017.
Abbott said it decided to recall the devices because physicians may experience difficulty in removing the protective balloon sheath, which can make it difficult to inflate or deflate the balloon during procedures. Patients may suffer air embolism, thrombosis, heart attack or death due to the malfunction, the company added in a statement.
FDA has classified this as a Class I recall, the most serious. In one case, failure to deflate the balloon necessitated surgery, which resulted in multiple post-surgical complications, and the patient died. Nineteen other injuries related to the catheters were reported to FDA.
Abbott, which began notifying customers of the recall in March, said up to 449,661 catheters that have been distributed may be affected. The cumulative frequency of reported events in difficulty of removing the sheath, and inflation and deflation of the balloon, is 0.12 percent worldwide, the company added.
The catheters are indicated for balloon dilation of :
? the stenotic portion of a coronary artery or bypass graft stenosis, to improve blood flow to the heart;
? a blocked or clogged artery to restore blood flow in heart attack patients; and
? a stent after implantation (2.00 mm - 5.00 mm balloon models only).
"All customers have been notified to cease using the products and have confirmed to Abbott that the products are no longer in use," Abbott spokeswoman Mary Kokkinen told Qmed in an email.
Catheters made by a variety of manufacturers have been subject to recall in the past few years. In February 2016, Arrow International, a division of Teleflex Inc., recalled 47,140 of its Intra-Aortic Balloon Catheter Kit and Percutaneous Insertion Kits because the sheath body could separate from the hub during insertion. The problem could cause significant bleeding and interrupt the balloon's ability to increase blood flow. One patient died and six others suffered serious injuries.
Between 2015 and 2016, Cook Medical recalled more than 400,000 angiographic catheters, due to tip-splitting. Other manufacturers' catheters have been subject to several previous recalls due to the potential for materials breaking off the devices and entering a patient's bloodstream.
FDA cited a similar danger from the manufacturing process in a September recall of nearly 16,000 catheters made by Vascular Solutions of Maple Grove, MN. Nearly 6,000 of the recalled Twin-Pass catheters were distributed in the United States between October 2014 and September 2016.
Nancy Crotti is a contributor to Qmed.
[Image credit: FDA]
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