The U.S. Food and Drug Administration (FDA) has issued a class 1 recall of the International Intra-Aorta Balloon Catheter Kits and Percutaneous Insertion Kits (IAB). The Teleflex company kits have been recalled because the sheath body may become separated from the sheath hub. If the situation is not addressed with prompt intervention, there may be significant blood loss or exsanguination.
At the time of the recall, 47,140 units were recalled from hospitals, clinics, medical centers in the United States and worldwide. To date, 13 adverse events were reported, and one (1) death. The FDA quotes the criteria for the class 1 recall: “A situation in which there is a reasonable probability that the use or exposure to a violate product will cause serious health consequences or death.”
The IAB is inserted in the aorta and provides mechanical circulatory support for heart patients. It inflates and deflates at different phases of the cardiac cycle to increase the output and decrease the work of the heart.
Adding to this bad news for the company, Fierce Medical Devices reports that Teleflex is struggling with impending layoffs, restructuring, and outsourcing as part of their impending restructuring.
Teleflex Incorporated notified distributors and customers by an Urgent Medical Device recall letter dated February 11, 2016. Patients those with affected products are advised to immediately discontinue use and return the device to Teleflex.