FDA Device recall Z-1899-2021
VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F 14/40/1200mm OUS
- FDA Device
- Class II
- ongoing
- Published 2021-06-23
On 2021-06-23 the FDA classified a Class II recall of VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F 14/40/1200mm OUS by Bard Peripheral Vascular, citing reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1899-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-12-14 |
| Published | 2021-06-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bard Peripheral Vascular |
| Distribution | US |
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
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Identifiers
| code_info | Product Code/GTIN: VENEL14040 /00801741102295; VENEL14060 /00801741102301; VENEL14080 /00801741102318; VENEL14100 /…Product Code/GTIN: VENEL14040 /00801741102295; VENEL14060 /00801741102301; VENEL14080 /00801741102318; VENEL14100 /00801741102325; VENEL14120 /00801741102332; VENEL14140 /00801741102349; VENEL14160 /00801741102356; VENEM14040 /00801741102226; VENEM14060 /00801741102233; VENEM14080 /00801741102240; VENEM14100 /00801741102257; VENEM14120 /00801741102264; VENEM14140 /00801741102271; VENEM14160 /00801741102288; VENUL14040 /00801741103483; VENUL14060 /00801741103490; VENUL14080 /00801741103506; VENUL14100 /00801741103513; VENUL14120 /00801741103520; VENUL14140 /00801741103537; VENUL14160 /00801741103544; VENUM14040 /00801741103414; VENUM14060 /00801741103421; VENUM14080 /00801741103438; VENUM14100 /00801741103445; VENUM14120 /00801741103452; VENUM14140 /00801741103469; VENUM14160 /00801741103476; U.S. Device Serial Numbers: ANEP2484; ANEP2485; ANEP2487; ANEP3962; ANEP3964; ANEP3966; ANEP3968; ANEP3972; ANEP3973; ANEP3979; ANEP3982; ANEP3986; ANEP5 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1899-2021%22
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