Arrow Recalls Intra-Aortic Balloon Catheter Kits

March 11, 2016

MORRISVILLE, NC — Endovascular device maker Arrow International has announced a voluntary class I recall of some of its intra-aortic balloon catheter and percutaneous insertion kits[1].

The FDA has been notified of the recall of about 47,000 units (product codes and lot numbers) sent to hospitals around the world, according to the company's letter to its customers dated February 11, 2016 and distributed by parent company Teleflex.

The recall is "due to the possibility that the sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. If bleeding is not addressed with prompt intervention, it may result in loss of significant blood volume or exsanguination. In addition, delay of treatment, interruption of treatment, or loss of [intra-aortic balloon] IAB therapy can occur."


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