Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F Recalled by Bard Peripheral Vascular Inc Due to Reports of the proximal end of the stent...
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 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;
Quantity: Total Devices=23,029 (U.S.=16,582; O.U.S. =6,447)
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.
About Bard Peripheral Vascular Inc
Bard Peripheral Vascular Inc has 136 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report