FDA Device recall Z-2041-2021
CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L
- FDA Device
- Class II
- ongoing
- Published 2021-07-14
On 2021-07-14 the FDA classified a Class II recall of CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L by Medtronic Heart Valves Division, citing due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2041-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-06-11 |
| Published | 2021-07-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Heart Valves Division |
| Distribution | AK, AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
Product
CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;
Reason
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Identifiers
| code_info | Model Number/Description: ENVEOR-L/DELIV SYS EnVeoR-L OREVAC 18Fr GTIN: 00643169800922 Lot Numbers: 0010199879; 001…Model Number/Description: ENVEOR-L/DELIV SYS EnVeoR-L OREVAC 18Fr GTIN: 00643169800922 Lot Numbers: 0010199879; 0010204030; 0010209069; 0010209070; 0010279048; 0010281657; 0010289860; 0010296299; Model Number/Description: ENVEOR-N/DELIV SYS EnVeoR-N OREVAC 20Fr GTIN: 00643169800946 Lot Numbers 0010199873; 0010199874; 0010209064; 0010211942; 0010253924; 0010258778; 0010260161; 0010262936; 0010289861; 0010296302; 0010297110; 0010301887; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2041-2021%22
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