Teleflex Incorporated Comments on Arrow International, Inc. Worldwide Voluntary Recall for the 5800 Series Intra-Aortic Balloon Catheters with Super Arrow-Flex(R) Sheath Introducers
Published: Dec 22, 2010
LIMERICK, Pa.--(BUSINESS WIRE)--Teleflex Incorporated’s subsidiary, Arrow International, today announced a worldwide voluntary recall of its 5800 Series Intra-Aortic Balloon Catheters with Super Arrow-Flex® Sheath Introducer. This recall is being conducted because of an increase of “stuck in sheath” reports involving the use of the Super Arrow-Flex® Sheath with 5800 Series IAB products. The U.S. Food and Drug Administration has classified this action as a Class I recall.