Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL16040 Venovo 10F Recalled by Bard Peripheral Vascular Inc Due to Reports of the proximal end of the stent...

Date: December 14, 2020
Company: Bard Peripheral Vascular Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Bard Peripheral Vascular Inc directly.

Affected Products

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

Quantity: Total Devices=57,515 (U.S.=46,878; O.U.S.=10,637)

Why Was This Recalled?

Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Bard Peripheral Vascular Inc

Bard Peripheral Vascular Inc has 136 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report