EnVeo R Loading System — Class I medical device recall Z-2264-2015
Terminated recall by Medtronic Cardiovascular Surgery-the Heart Valve Division, reported 2015-08-12, distributed nationwide. Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate.
| Recall number | Z-2264-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Cardiovascular Surgery-the Heart Valve Division, Santa Ana, CA, United States |
| Recall initiated | 2015-07-15 |
| Classified | 2015-08-05 |
| Reported by FDA | 2015-08-12 |
| Terminated | 2016-05-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CZ, DE, DK, DO, EE, ES, FI, FR, GB, GR, HK, IE, IL, IT, KW, LT, LV, NL, NO, NZ, PH, PL, PT, QA, SA, SE, SG, SI, TR |
| Reason classes | specification failure |
| Model numbers | LS-ENVEOR-23, LS-ENVEOR-23-C, LS-ENVEOR-2629, LS-ENVEOR-2629-C |
Product
EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.
Reason for recall
Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate.
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-2264-2015. 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.