Medical Device Safety and Recalls: Arrow International Inc. Recalls Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits Due to Sheath Separation Issue

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Arrow International Inc. Recalls Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits Due to Sheath Separation Issue

Arrow International Inc. is recalling the Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits because the sheath body may separate from the sheath hub during the insertion procedure. This may cause significant bleeding if not addressed promptly and an interruption of the inflating-deflating balloon therapy.

The FDA has received 13 medical device reports of serious adverse health consequences, including one death related to this device malfunction.

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