Home / Recalls / Medtronic Inc. Cardiac Rhythm Disease Management / Z-0995-2014

Z-0995-2014 Class II Terminated

Recalled by Medtronic Inc. Cardiac Rhythm Disease Management — Saint Paul, MN

Recall Details

Product Type
Devices
Report Date
February 26, 2014
Initiation Date
January 30, 2014
Termination Date
October 6, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19483 total (7669 US, 11814 OUS)

Product Description

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 for Recall

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.

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.

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.

Other recalls by Medtronic Inc. Cardiac Rhythm Disease Management

  • Z-0022-2016 Class II — Medtronic Medical Device Identification Card for SureScan pacemaker patients. (September 15, 2015)
  • Z-2777-2015 Class II — Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing c (September 1, 2015)
  • Z-1365-2015 Class II — Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx onl (March 23, 2015)
  • Z-1356-2015 Class II — Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Us (March 17, 2015)
  • Z-1276-2015 Class I — Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Se (February 23, 2015)
  • Z-1661-2014 Class II — Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generat (April 29, 2014)
  • Z-0997-2014 Class II — Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vent (January 30, 2014)
  • Z-0999-2014 Class II — Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB787 (January 30, 2014)
  • Z-0996-2014 Class II — Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-Vent (January 30, 2014)
  • Z-0998-2014 Class II — Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 ( (January 30, 2014)