FDA Device recall Z-0997-2014
Medtronic Select 3D Arterial Cannulae
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of Medtronic Select 3D Arterial Cannulae by Medtronic Cardiac Rhythm Disease Management, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0997-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-30 |
| Published | 2014-02-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Cardiac Rhythm Disease Management |
| Distribution | US |
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.
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.
Identifiers
| code_info | Model 78624, Lot numbers: 2011010432, 2011010514, 2011010515, 2011011141, 2011011543, 2011021907, 2011040344, 201104…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0997-2014%22
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