VENOVO Venous Stent System 9F Product Description — Class II medical device recall Z-1899-2021
Ongoing recall by Bard Peripheral Vascular Inc, reported 2021-06-23, distributed nationwide. Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to
| Recall number | Z-1899-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Peripheral Vascular Inc, Tempe, AZ, United States |
| Recall initiated | 2020-12-14 |
| Classified | 2021-06-17 |
| Reported by FDA | 2021-06-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BR, CH, CL, CR, CY, CZ, DK, DZ, EG, ES, FI, FR, GB, GR, HK, HU, IE, IL, IN, IQ, IR, IT, JO, KR, MX, MY, NL, NO, OM, PA, PL, PT, RO, RU, SE, SG, SI, SK, TR, TW, VN, ZA |
| UPC / GTIN / UDI-DI | 00801741102226, 00801741102233, 00801741102240, 00801741102257, 00801741102264, 00801741102271, 00801741102288, 00801741102295, 00801741102301, 00801741102318, 00801741102325, 00801741102332, 00801741102349, 00801741102356, 00801741103414, 00801741103421, 00801741103438, 00801741103445, 00801741103452, 00801741103469, 00801741103476, 00801741103483, 00801741103490, 00801741103506, 00801741103513 and 3 more |
| Serial numbers | ANBY3260, ANBZ2682, ANCN1544, ANCQ0143, ANCQ0145, ANCQ1441, ANCQ1442, ANCQ3791, ANCR1294, ANCS3349, ANCS3350, ANCT1149, ANCT1579, ANCT2425, ANCT2432, ANCT3621, ANCT4325, ANCU1842, ANCU3712, ANCU3713, ANCV0499, ANCV3482, ANCV4708, ANCW1433, ANCW2271 and 475 more |
| Model numbers | VENEL14040 |
Product
VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F 14/40/1200mm OUS; VENEL14060 /Venovo 9F 14/60/1200mm OUS; VENEL14080 /Venovo 9F 14/80/1200mm OUS; VENEL14100 /Venovo 9F 14/100/1200mm OUS; VENEL14120 /Venovo 9F 14/120/1200mm OUS; VENEL14140 /Venovo 9F 14/140/1200mm OUS; VENEL14160 /Venovo 9F 14/160/1200mm OUS; VENEM14040 /Venovo 9F 14/40/800mm OUS; VENEM14060 /Venovo 9F 14/60/800mm OUS; VENEM14080 /Venovo 9F 14/80/800mm OUS; VENEM14100 /Venovo 9F 14/100/800mm OUS; VENEM14120 /Venovo 9F 14/120/800mm OUS; VENEM14140 /Venovo 9F14/140/800mm OUS; VENEM14160 /Venovo 9F 14/160/800mm OUS; VENUL14040 /Venovo 9F 14/40/1200mm US; VENUL14060 /Venovo 9F 14/60/1200mm US; VENUL14080 /Venovo 9F 14/80/1200mm US; VENUL14100 /Venovo 9F 14/100/1200mm US; VENUL14120 /Venovo 9F 14/120/1200mm US; VENUL14140 /Venovo 9F 14/140/1200mm US; VENUL14160 /Venovo 9F 14/160/1200mm US; VENUM14040 /Venovo 9F 14/40/800mm US; VENUM14060 /Venovo 9F 14/60/800mm US; VENUM14080 /Venovo 9F 14/80/800mm US; VENUM14100 /Venovo 9F 14/100/800mm US; VENUM14120 /Venovo 9F 14/120/800mm US; VENUM14140 /Venovo 9F 14/140/800mm US; VENUM14160 /Venovo 9F 14/160/800mm US;
Reason for recall
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
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-1899-2021. 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.