Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae both have clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of the cannula includes a 3/8" (0.95 cm) vented or non-vented connector with a peel cap. The vented connector allows air to be vented from the cannula before connection to the perfusion line. The Select 3D Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body features a tip orientation line indicating direction of the cannula tip during cannulation. Overall cannula length is 11.5" (29.2 cm). These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.

Reason: Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.

Code information: Model 78618, Lot numbers: 2011041199, 2011062306, 2011100971, 2011102092, 2011120307, 2012051764, 2012061644, 2012080274, 2012110107, 2012120373, 2013010071, 2013050197, 2013081170, 2013102358, 201203C853. Model 78620, Lot numbers: 2011030255, 2011040939, 2011041341, 2011101160 2011111043, 2012011041, 2012020540, 2012070617, 2012110017, 2012111257, 2013031297, 2013050408, 2013060024, 2013060816, 2013070896, 2013090420, 2013091570, 2013101359. Model 78718, Lot numbers: 2011020219, 2011051461, 2011051501, 2011060279, 2011081265, 2011091551, 2011100022, 2011111305, 2012011048, 2012032171, 2012040645, 2012070832, 2012071313, 2013031493, 2013041737, 2013051367, 2013060409, 2013091960, 2013102157, 2013110588, 201110C116, 201203C855. Model 78720, Lot numbers: 2011010067, 2011021825, 2011062606, 2011062607, 2011070536, 2011071117, 2011080605, 2011081029, 2011081501, 2011082463, 2011090046, 2011090047, 2011100092, 2012011142, 2012011424, 2012051863, 2012060210, 2012061344, 2012061868, 2012120133, 2012120781, 2012120941, 2012121072, 2013030331, 2013030943, 2013080633, 2013081206, 2013110894, 2013120553.

Distribution pattern: Worldwide distribution: US (Nationwide) including Puerto Rico, and Internationally to: Algeria, Argentina, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Cyprus, El Salvador, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Jordan, Kuwait, Netherlands, Oman, Paraguay, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela, and Yemen.