FDA Device recall Z-2546-2016
Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical b…
- FDA Device
- Class II
- terminated
- Published 2016-08-24
On 2016-08-24 the FDA classified a Class II recall of Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical b… by Medtronic Cardiovascular Surgery The Heart Valve Division, citing potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2546-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-03 |
| Published | 2016-08-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Cardiovascular Surgery The Heart Valve Division |
| Distribution | PR |
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
Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS).
Identifiers
| code_info | all lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2546-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.