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.”

Read the FDA announcement.

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Cardiac Surgery and Heart Failure, Mechanical Circulatory Support

Keywords: Heart-Assist Devices, Hemorrhage, Intra-Aortic Balloon Pumping, United States Food and Drug Administration

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