Medtronic Inc. Cardiac Rhythm Disease Management: 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.

Recall number

Z-0997-2014

Recalling firm

Medtronic Inc. Cardiac Rhythm Disease Management

Product

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.

Status

Terminated

Initiated

2014-01-30

Posted

2014-02-20

Terminated

2014-10-06

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.

Root cause

Under Investigation by firm

Action

The firm, Medtronic, sent an "Urgent Medical Device Recall" letter dated January, 2014 via UPS on January 30, 2014 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately identify and quarantine all listed product in your inventory; return all listed product to Medtronic and contact Customer Service at 800 854-3570 and reference RADAR #167826 to initiate a return and credit of product; complete and return the attached Customer Confirmation Certificate via fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality, and share this notification with others in your organization as appropriate. Select 3D and Select CAP Arterial Cannula are not available for purchase at this time. Please contact your Medtronic sales representative or Medtronic LifeLine Technical Services at 1 877-526-7890 or (+1 763) 526-7890 to assist with alternative cannula selection and any additional questions you may have related to this notification.

Quantity

19483 total (7669 US, 11814 OUS)

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.

Lot, serial or model codes

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.

510(k) numbers

["K000776"]

PMA numbers

not on file

Product code

DWF

Firm FEI

2182208

Firm city

Saint Paul

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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