Medtronic Intersept Custom Tubing Pack which contain Select 3D or… — Class II medical device recall Z-1000-2014
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-1000-2014 |
|---|---|
| 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 | 12227513, 12277464, 206420618, 206499164, 206618641, 206842458, 206932996, 207184816 |
| Model numbers | 3Y90R3, C300901B |
Product
Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide. Non-pyrogenic. The design and components of this product are specified by the user. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures.
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-1000-2014. 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.