FDAFDA · Food and drugs·Recall number Z-0996-2014
Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-Vented Cannulae, model 78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached to a molded, clear, flexible PVC tapered body or wirebound PVC body. The cannula body features a tip orientation line to indicate direction of the cannula tip during cannulation. The proximal end of the cannula includes a connection site or a molded 0.95 cm (3/8 in) barbed connector with or without a molded plastic vent plug or peel cap. The vent plug or peel cap allows air to be vented from the cannula before connection to the perfusion line. These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.
Published February 26, 2014 · Recall initiated: January 30, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Inc. Cardiac Rhythm Disease Management
- Distributor
- 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.
- Lot
- Model 78622, Lot numbers: 2011031714, 2011040345, 2011050373, 2011060471, 2011060641, 2011060642, 2011070099, 2011072408, 2011081502, 2011102965, 2011111215, 2011120575, 2012011143, 2012011425, 2012020052, 2012040536, 2012051387, 2012090216, 2012101333 ,2013010957, 2013011791, 2013020303, 2013030729, 2013040209, 2013040282, 2013040710, 2013041272, 2013051447, 2013060736, 2013071836, 2013072009, 201105C105, 201203C854. Model 78722, Lot numbers: 2011031588, 2011031885, 2011051006, 2011051226, 2011061585, 2011071672, 2011082216, 2011091825 , 2011101670, 2011102093, 2011110717, 2011120059, 2012060478, 2012061056, 2012061057, 2012061725, 2012070570, 2012090657, 2013011121, 2013021260, 2013030685, 2013040494, 2013040595, 2013070162, 2013070483, 2013081289, 2013081603, 201108C227.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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