FDA Device recall Z-2042-2021
CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14
- FDA Device
- Class II
- ongoing
- Published 2021-07-14
On 2021-07-14 the FDA classified a Class II recall of CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14 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-2042-2021 |
| 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 PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;
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: ENVPRO-14-US/18FR DELIV SYS ENVPRO-14-US GTIN:00643169987203 Lot Numbers: 0009679690; 000…Model Number/Description: ENVPRO-14-US/18FR DELIV SYS ENVPRO-14-US GTIN:00643169987203 Lot Numbers: 0009679690; 0009688651; 0009690887; 0009693142; 0009716570; 0009718679; 0009724715; 0009735112; 0009747816; 0009747817; 0009769716; 0009780304; 0009780312; 0009813675; 0009819798; 0009833186; 0009833187; 0009835584; 0009884743; 0009903576; 0009909651; 0009911878; 0009916760; 0009674373; Model Number/Description: ENVPRO-14/18FR DELIV SYS ENVPRO-14 GTIN: 00643169987258 Lot Numbers 0009674373; 0009677041; 0009681843; 0009686572; 0009696943; 0009702501; 0009708314; 0009720707; 0009730833; 0009732864; 0009735111; 0009741277; 0009745282; 0009751537; 0009751539; 0009753928; 0009753930; 0009759086; 0009763571; 0009765704; 0009765705; 0009769796; 0009771781; 0009778377; 0009780306; 0009780315; 0009797642; 0009801629; 0009801632; 0009815902; 0009815904; 0009819795; 0009824816; 0009827178; 0009827180; 0009831363; 0009831364; 00098 |
|---|
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-2042-2021%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.