Medtronic EnVeo R Delivery Catheter System — Class II medical device recall Z-2546-2016
Terminated recall by Medtronic Cardiovascular Surgery-the Heart Valve Division, reported 2016-08-24, distributed in PR. Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS).
| Recall number | Z-2546-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Cardiovascular Surgery-the Heart Valve Division, Santa Ana, CA, United States |
| Recall initiated | 2016-08-03 |
| Classified | 2016-08-16 |
| Reported by FDA | 2016-08-24 |
| Terminated | 2017-03-31 |
| Distributed | PR |
| Countries outside the US | AE, AT, AU, BE, BR, CH, CO, CR, CZ, DE, DK, DO, EE, EG, ES, FI, FR, GB, GR, HK, HU, IE, IL, IN, IR, IS, IT, KR, KW, LB, LT, LU, LV, MA, MY, NL, NO, NZ, OM, PA, PE, PH, PL, PT, QA, RO, SA, SE, SG, SI, SK, TH, TN, TR, TT, VE, ZA |
| Quantity | 7,319 units |
Product
Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve.
Reason for recall
Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS).
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-2546-2016. 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.