On February 11, 2016, Arrow International, a division of Teleflex, announced a global recall of its Intra-Aortic Balloon (IAB) Catheter Kits and Percutaneous Insertion Kits. The recall was initiated on February 9, 2016.
Arrow International first received approval for IABs in 1996 as 510k devices. The FDA’s 510k process allows manufacturers to bypass clinical testing as long as the device is similar to products currently on the market.
Arrow IAB is designed to provide cardiac assist therapy. It is inserted in the aorta, and “provides mechanical circulatory support for cardiac patients, by inflating and deflating at different phases of the cardiac cycle to increase cardiac output and decrease the work of the heart.” Arrow Percutaneous Insertion Kits serve as IAB catheter accessories. Both the IAB Catheter Kits and Percutaneous Insertion Kits contain sheath components.
In its Urgent Medical Device Recall Notification, Arrow International warned that the recalled devices suffer from a defect that can result in separation of the sheath body from the sheath hub. This can lead to loss of IAB therapy, bleeding with significant blood loss, and even death.
On March 11, 2016, the FDA classified the recall of these defective medical devices as Class I. This is the most serious type of recall used when “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” The worldwide recall involves over 47,000 units. Consumers are advised to immediately discontinue the use of the affected products. By the time of the recall, 13 adverse events have been reported, “including 6 serious injuries and 1 death.”
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At Kaiser Gornick LLP, one of our experienced product liability lawyers can discuss your options for recovering compensation. Many injured patients face devastating physical, financial, and emotional losses after suffering from permanent damage caused by the medical device. We can help you seek damages for economic and non-economic damages stemming from your injuries.