Medtronic Select CAP Arterial Cannulae — Class II medical device recall Z-0998-2014
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-0998-2014 |
|---|---|
| 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 | 2011011178, 2011011187, 2011020121, 2011020785, 2011021532, 2011021826, 2011041201, 2011041542, 2011050717, 2011062305, 201106C038, 2011070534, 2011070801, 2011072337, 2011080058, 2011080606, 2011081266, 2011081545, 2011081637, 2011082464, 2011090245, 2011090483, 2011110207, 2011110914, 2011111844, 2011120308, 2012012160, 2012021436, 2012021695, 2012031176, 2012051794, 2012070891, 2012071268, 2012071735, 2012100256, 2012111224, 2013010416, 2013030273, 2013030583, 2013050807 and 9 more |
| Model numbers | 78818, 78820, 78822, 78920, 78922, 78924 |
Product
Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 (20 Fr.), 78822 (22 Fr.). Non-Vented Cannulae, model 78920 (20 Fr.), 78922 (22 Fr.), 78924 (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. The proximal end features a pressure monitoring line with a 3-way stopcock. 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
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0998-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.