FDA Device recall Z-1898-2021

VENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10040 /Venovo 8F 10/40/1200mm 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 8F Product Description(REF)/dimension: VENEL10040 /Venovo 8F 10/40/1200mm 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-1898-2021
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 8F Product Description(REF)/dimension: VENEL10040 /Venovo 8F 10/40/1200mm OUS; VENEL10060 /Venovo 8F 10/60/1200mm OUS; VENEL10080 /Venovo 8F 10/80/1200mm OUS; VENEL10100 /Venovo 8F 10/100/1200mm OUS; VENEL10120 /Venovo 8F 10/120/1200mm OUS; VENEL10140 /Venovo 8F 10/140/1200mm OUS; VENEL10160 /Venovo 8F10/160/1200mm OUS; VENEL12040 /Venovo 8F 12/40/1200mm OUS; VENEL12060 /Venovo 8F 12/60/1200mm OUS; VENEL12080 /Venovo 8F 12/80/1200mm OUS; VENEL12100 /Venovo 8F 12/100/1200mm OUS; VENEL12120 /Venovo 8F 12/120/1200mm OUS; VENEL12140 /Venovo 8F 12/140/1200mm OUS; VENEL12160 /Venovo 8F 12/160/1200mm OUS; VENEM10040 /Venovo 8F 10/40/800mm OUS; VENEM10060 /Venovo 8F 10/60/800mm OUS; VENEM10080 /Venovo 8F 10/80/800mm OUS; VENEM10100 /Venovo 8F 10/100/800mm OUS; VENEM10120 /Venovo 8F 10/120/800mm OUS; VENEM10140 /Venovo 8F 10/140/800mm OUS; VENEM10160 /Venovo 8F 10/160/800mm OUS; VENEM12040 /Venovo 8F 12/40/800mm OUS; VENEM12060 /Venovo 8F 12/60/800mm OUS; VENEM12080 /Venovo 8F 12/80/800mm OUS; VENEM12100 /Venovo 8F 12/100/800mm OUS; VENEM12120 /Venovo 8F 12/120/800mm OUS; VENEM12140 /Venovo 8F 12/140/800mm OUS; VENEM12160 /Venovo 8F 12/160/800mm OUS; VENUL10040 /Venovo 8F 10/40/1200mm US; VENUL10060 /Venovo 8F 10/60/1200mm US; VENUL10080 /Venovo 8F 10/80/1200mm US; VENUL10100 /Venovo 8F 10/100/1200mm US; VENUL10120 /Venovo 8F 10/120/1200mm US; VENUL10140 /Venovo 8F 10/140/1200mm US; VENUL10160 /Venovo 8F 10/160/1200mm US; VENUL12040 /Venovo 8F 12/40/1200mm US; VENUL12060 /Venovo 8F 12/60/1200mm US; VENUL12080 /Venovo 8F 12/80/1200mm US; VENUL12100 /Venovo 8F 12/100/1200mm US; VENUL12120 /Venovo 8F 12/120/1200mm US; VENUL12140 /Venovo 8F 12/140/1200mm US; VENUL12160 /Venovo 8F 12/160/1200mm US; VENUM10040 /Venovo 8F 10/40/800mm US; VENUM10060 /Venovo 8F 10/60/800mm US; VENUM10080 /Venovo 8F 10/80/800mm US; VENUM10100 /Venovo 8F 10/100/800mm US; VENUM10120 /Venovo 8F 10/120/800mm US; VENUM10140 /Venovo 8F 10/140/800mm US; VENUM10160 /Venovo 8F 10/160/800mm US; VENUM12040 /Venovo 8F 12/40/800mm US; VENUM12060 /Venovo 8F 12/60/800mm US; VENUM12080 /Venovo 8F 12/80/800mm US; VENUM12100 /Venovo 8F 12/100/800mm US; VENUM12120 /Venovo 8F 12/120/800mm US; VENUM12140 /Venovo 8F 12/140/800mm US; VENUM12160 /Venovo 8F 12/160/800mm 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: VENEL10040 /00801741102004; VENEL10060 /00801741104664; VENEL10080 /00801741104671; VENEL10100 /… Product Code/GTIN: VENEL10040 /00801741102004; VENEL10060 /00801741104664; VENEL10080 /00801741104671; VENEL10100 /00801741102035; VENEL10120 /00801741102042; VENEL10140 /00801741102059; VENEL10160 /00801741102066; VENEL12040 /00801741102141; VENEL12060 /00801741102158; VENEL12080 /00801741102172; VENEL12100 /00801741102189; VENEL12120 /00801741102196; VENEL12140 /00801741102202; VENEL12160 /00801741102219; VENEM10040 /00801741101939; VENEM10060 /00801741101946; VENEM10080 /00801741101953; VENEM10100 /00801741101960; VENEM10120 /00801741101977; VENEM10140 /00801741101984; VENEM10160 /00801741101991; VENEM12040 /00801741102073; VENEM12060 /00801741102080; VENEM12080 /00801741102097; VENEM12100 /00801741102103; VENEM12120 /00801741102110; VENEM12140 /00801741102127; VENEM12160 /00801741102134; VENUL10040 /00801741103209; VENUL10060 /00801741103216; VENUL10080 /00801741103223; VENUL10100 /00801741103230; VENUL10120 /00801741103247; VENUL10140 /00801741103

code_info

Product Code/GTIN: VENEL10040 /00801741102004; VENEL10060 /00801741104664; VENEL10080 /00801741104671; VENEL10100 /…

Product Code/GTIN: VENEL10040 /00801741102004; VENEL10060 /00801741104664; VENEL10080 /00801741104671; VENEL10100 /00801741102035; VENEL10120 /00801741102042; VENEL10140 /00801741102059; VENEL10160 /00801741102066; VENEL12040 /00801741102141; VENEL12060 /00801741102158; VENEL12080 /00801741102172; VENEL12100 /00801741102189; VENEL12120 /00801741102196; VENEL12140 /00801741102202; VENEL12160 /00801741102219; VENEM10040 /00801741101939; VENEM10060 /00801741101946; VENEM10080 /00801741101953; VENEM10100 /00801741101960; VENEM10120 /00801741101977; VENEM10140 /00801741101984; VENEM10160 /00801741101991; VENEM12040 /00801741102073; VENEM12060 /00801741102080; VENEM12080 /00801741102097; VENEM12100 /00801741102103; VENEM12120 /00801741102110; VENEM12140 /00801741102127; VENEM12160 /00801741102134; VENUL10040 /00801741103209; VENUL10060 /00801741103216; VENUL10080 /00801741103223; VENUL10100 /00801741103230; VENUL10120 /00801741103247; VENUL10140 /00801741103

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-1898-2021%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.