Arrow Intra-Aortic Balloon Recalled After 1 Death, 6 Serious Injuries

(March 15, 2016, 2:37 PM EDT) -- SILVER SPRING, Md. — Teleflex Inc. on Feb. 9 initiated an urgent, voluntary, worldwide Class I recall of 47,140 Arrow International Intra-Aortic Balloon (IAB) Catheter Kits and Percutaneous Insertion Kits after one death and six serious injuries when the device’s sheath separated from the hub, the Food and Drug Administration announced March 11.

The FDA said the Arrow IAB is inserted in the aorta and provides mechanical circulatory support for cardiac patients by inflating and deflating at different phases of the cardiac cycle to increase cardiac...
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