10 Biggest Medical Device Recalls of 2016—Arrow International

Device: Specific models of Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits

Recall reason: According to information on the FDA recall page, "the sheath body may separate from the sheath hub during the insertion procedure. This may cause significant bleeding . . . and an interruption of the inflating-deflating balloon therapy."

When recall was initiated: February 10, 2016

Number of U.S. units impacted: 13,405 units

For more information, visit the FDA Recall page.