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]
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