Devices

Device Recall Medtronic Select 3D Arterial Cannula

  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease Management
  • 1 Event

Fabricant

Medtronic Inc. Cardiac Rhythm Disease Management
  • Adresse du fabricant
    Medtronic Inc. Cardiac Rhythm Disease Management, 8200 Coral Sea St NE, Saint Paul MN 55112-4391
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

2 dispositifs médicaux avec un nom similaire

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Device Recall Medtronic Select 3D Arterial Cannula
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease Management
Device Recall Medtronic Select 3D Arterial Cannula
  • Modèle / numéro de série
    Model 78624, Lot numbers: 2011010432, 2011010514, 2011010515, 2011011141,  2011011543, 2011021907, 2011040344, 2011040946, 2011060613, 2011060865,  2011070535, 2011071749, 2011081635, 2011110330, 2011120304, 2011120305,  2011121133, 2012060424, 2012060431, 2012070886, 2012080324, 2012081353,  2012081928, 2012090013, 2012120521, 2012121021, 2012121414, 2013031142,  2013050555, 2013050805, 2013051225, 2013051640, 2013060249, 2013090499,  2013090570, 2013091332, 2013091924, 201106C140, 201203C844, 201310C579.   Model 78724, Lot numbers: 2011032145, 2011050718, 2011060852, 2011092067,  2011102225, 2012032345, 2012071614, 2012081704, 2012081973, 2013031364,  2013051818, 2013060581, 2013070831, 2013080858, 2013100654, 2013110548,  2014010275, 201108C228, 201203C842.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vented Cannulae, model 78724 (24 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.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease Management