Home / Recalls / Medtronic Inc. Cardiac Rhythm Disease Management / Z-0997-2014

Z-0997-2014 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, 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.

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 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.

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-0995-2014 Class II — Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (January 30, 2014)
  • Z-0996-2014 Class II — Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 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-0998-2014 Class II — Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 ( (January 30, 2014)