CoreValve Evolut PRO PLUS Delivery Catheter System — Class II medical device recall Z-2043-2021
Ongoing recall by Medtronic Heart Valves Division, reported 2021-07-14, distributed in AK, AL, AR, AZ, CA, CT, DC, DE…. Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactur
| Recall number | Z-2043-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Heart Valves Division, Santa Ana, CA, United States |
| Recall initiated | 2021-06-11 |
| Classified | 2021-07-08 |
| Reported by FDA | 2021-07-14 |
| Distributed | 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 |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CR, CW, CY, CZ, DE, DK, DO, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KR, KW, LB, LT, LU, LV, MT, MX, MY, NL, NO, NZ, OM, PA, PE, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, TH, TR, TW, UY, VE, VN, ZA |
| Quantity | 67,339 units |
| UPC / GTIN / UDI-DI | 00763000207854, 00763000207861 |
| Lot numbers | 0010165308, 0010165309, 0010165310, 0010165311, 0010165312, 0010165313, 0010169462, 0010169464, 0010171866, 0010171868, 0010171869, 0010173361, 0010175293, 0010175294, 0010181410, 0010181411, 0010181412, 0010182735, 0010182736, 0010188541, 0010192246, 0010192247, 0010197788, 0010197790, 0010199877, 0010199878, 0010199880, 0010204029, 0010216175, 0010216176, 0010222009, 0010222011, 0010225047, 0010271291, 0010271292, 0010271293, 0010273071, 0010279050, 0010279938, 0010288574 and 12 more |
| Model numbers | D-EVPROP2329US, D-EVPROP34USSA |
Product
CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;
Reason for recall
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
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-2043-2021. 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.