VENOVO Venous Stent System 10F Product Description — Class II medical device recall Z-1897-2021

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-1897-2021`
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	`00801741102363`, `00801741102370`, `00801741102387`, `00801741102394`, `00801741102400`, `00801741102417`, `00801741102424`, `00801741102431`, `00801741102448`, `00801741102455`, `00801741102462`, `00801741102479`, `00801741102486`, `00801741102493`, `00801741102509`, `00801741102516`, `00801741102523`, `00801741102530`, `00801741102547`, `00801741102554`, `00801741102561`, `00801741102578`, `00801741102585`, `00801741102592`, `00801741102608` and 59 more
Serial numbers	`ANCQ4297`, `ANCS1570`, `ANCU2730`, `ANCU3715`, `ANCX1871`, `ANDN0834`, `ANDP3970`, `ANDQ0330`, `ANDQ3051`, `ANDQ3886`, `ANDQ3890`, `ANDQ5221`, `ANDQ5229`, `ANDR0758`, `ANDS0723`, `ANDS0724`, `ANDS0725`, `ANDS0726`, `ANDS0727`, `ANDS0728`, `ANDS0733`, `ANDS0734`, `ANDS0735`, `ANDS0736`, `ANDS0737` and 475 more
Model numbers	`VENEL16040`

Product

VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL16040 Venovo 10F 16/40/1200mm OUS VENEL16060 Venovo 10F 16/60/1200mm OUS VENEL16080 Venovo 10F 16/80/1200mm OUS VENEL16100 Venovo 10F 16/100/1200mm OUS VENEL16120 Venovo 10F 16/120/1200mm OUS VENEL16140 Venovo 10F 16/140/1200mm OUS VENEL16160 Venovo 10F 16/160/1200mm OUS VENEL18040 Venovo 10F 18/40/1200mm OUS VENEL18060 Venovo 10F 18/60/1200mm OUS VENEL18080 Venovo 10F 18/80/1200mm OUS VENEL18100 Venovo 10F 18/100/1200mm OUS VENEL18120 Venovo 10F 18/120/1200mm OUS VENEL18140 Venovo 10F 18/140/1200mm OUS VENEL18160 Venovo 10F 18/160/1200mm OUS VENEL20040 Venovo 10F 20/40/1200mm OUS VENEL20060 Venovo 10F 20/60/1200mm OUS VENEL20080 Venovo 10F 20/80/1200mm OUS VENEL20100 Venovo 10F 20/100/1200mm OUS VENEL20120 Venovo 10F 20/120/1200mm OUS VENEL20140 Venovo 10F 20/140/1200mm OUS VENEL20160 Venovo 10F 20/160/1200mm OUS VENEM16040 Venovo 10F 16/40/800mm OUS VENEM16060 Venovo 10F 16/60/800mm OUS VENEM16080 Venovo 10F 16/80/800mm OUS VENEM16100 Venovo 10F 16/100/800mm OUS VENEM16120 Venovo 10F 16/120/800mm OUS VENEM16140 Venovo 10F 16/140/800mm OUS VENEM16160 Venovo 10F 16/160/800mm OUS VENEM18040 Venovo 10F 18/40/800mm OUS VENEM18060 Venovo 10F 18/60/800mm OUS VENEM18080 Venovo 10F 18/80/800mm OUS VENEM18100 Venovo 10F 18/100/800mm OUS VENEM18120 Venovo 10F 18/120/800mm OUS VENEM18140 Venovo 10F 18/140/800mm OUS VENEM18160 Venovo 10F 18/160/800mm OUS VENEM20040 Venovo 10F 20/40/800mm OUS VENEM20060 Venovo 10F 20/60/800mm OUS VENEM20080 Venovo 10F 20/80/800mm OUS VENEM20100 Venovo 10F 20/100/800mm OUS VENEM20120 Venovo 10F 20/120/800mm OUS VENEM20140 Venovo 10F 20/140/800mm OUS VENEM20160 Venovo 10F 20/160/800mm OUS VENUL16040 Venovo 10F 16/40/1200mm US VENUL16060 Venovo 10F 16/60/1200mm US VENUL16080 Venovo 10F 16/80/1200mm US VENUL16100 Venovo 10F 16/100/1200mm US VENUL16120 Venovo 10F 16/120/1200mm US VENUL16140 Venovo 10F 16/140/1200mm US VENUL16160 Venovo 10F 16/160/1200mm US VENUL18040 Venovo 10F 18/40/1200mm US VENUL18060 Venovo 10F 18/60/1200mm US VENUL18080 Venovo 10F 18/80/1200mm US VENUL18100 Venovo 10F 18/100/1200mm US VENUL18120 Venovo 10F 18/120/1200mm US VENUL18140 Venovo 10F 18/140/1200mm US VENUL18160 Venovo 10F 18/160/1200mm US VENUL20040 Venovo 10F 20/40/1200mm US VENUL20060 Venovo 10F 20/60/1200mm US VENUL20080 Venovo 10F 20/80/1200mm US VENUL20100 Venovo 10F 20/100/1200mm US VENUL20120 Venovo 10F 20/120/1200mm US VENUL20140 Venovo 10F 20/140/1200mm US VENUL20160 Venovo 10F 20/160/1200mm US VENUM16040 Venovo 10F 16/40/800mm US VENUM16060 Venovo 10F 16/60/800mm US VENUM16080 Venovo 10F 16/80/800mm US VENUM16100 Venovo 10F 16/100/800mm US VENUM16120 Venovo 10F 16/120/800mm US VENUM16140 Venovo 10F 16/140/800mm US VENUM16160 Venovo 10F 16/160/800mm US VENUM18040 Venovo 10F 18/40/800mm US VENUM18060 Venovo 10F 18/60/800mm US VENUM18080 Venovo 10F 18/80/800mm US VENUM18100 Venovo 10F 18/100/800mm US VENUM18120 Venovo 10F 18/120/800mm US VENUM18140 Venovo 10F 18/140/800mm US VENUM18160 Venovo 10F 18/160/800mm US VENUM20040 Venovo 10F 20/40/800mm US VENUM20060 Venovo 10F 20/60/800mm US VENUM20080 Venovo 10F 20/80/800mm US VENUM20100 Venovo 10F 20/100/800mm US VENUM20120 Venovo 10F 20/120/800mm US VENUM20140 Venovo 10F 20/140/800mm US VENUM20160 Venovo 10F 20/160/800mm 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-1897-2021. 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.