FDA Recalls Intra-Aortic Balloon Catheter and Percutaneous Insertion Kits
The U.S. Food and Drug Administration (FDA) has issued a class I recall for Teleflex Inc.’s Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits. According to the recall, the body of the sheath may separate from the sheath hub potentially causing bleeding in patients or interruption/loss of intra-aortic balloon pump treatment.
The FDA recommends that “consumers who have affected product should immediately discontinue use and return all affected product to Teleflex.”
Keywords: Heart-Assist Devices, Hemorrhage, Intra-Aortic Balloon Pumping, United States Food and Drug Administration
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