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. |
[Image courtesy of FDA RECALL PAGE]
Take the Medical Innovation Tours during the BIOMEDevice San Jose Conference and Expo, December 7-8. |