Medtronic Select CAP Arterial Cannulae — Class II medical device recall Z-0999-2014
Terminated recall by Medtronic Inc. Cardiac Rhythm Disease Management, reported 2014-02-26, distributed nationwide. Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to rep
| Recall number | Z-0999-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, United States |
| Recall initiated | 2014-01-30 |
| Classified | 2014-02-19 |
| Reported by FDA | 2014-02-26 |
| Terminated | 2014-10-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, BE, BR, CA, CH, CY, DE, DZ, ES, FR, GB, GR, HU, IE, IN, IT, JO, JP, KW, NL, OM, PL, PT, PY, SA, SE, SK, SV, TH, TR, VE |
| Lot numbers | 06867511, 12011874, 12086013, 12259014, 12286525, 206292900, 206784461 |
| Model numbers | CB78722 |
Product
Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae has 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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.