Device For Cardiac Bypass In Children Recalled

Law360, New York (December 8, 2008, 12:00 AM EST) -- A heart aid used during cardiac bypass surgeries in children is being recalled due to its risk of causing heart damage, blood loss and death, the U.S. Food and Drug Administration has announced.

Terumo Cardiovascular Systems Corp. issued an urgent nationwide recall in cooperation with the FDA on Dec. 1 for Tenderflow Pediatric Arterial Cannulae, a device used by cardiac surgeons in cardiopulmonary bypass operations.

The cannula is used to re-oxygenate the ascending aorta during bypass operations, a time when doctors rely on heart-lung machines in...
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