FDADecember 14, 2020device

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/...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

bard peripheral vascularbardbard peripheral

UPCs

008017411020040080174110466400801741104671008017411020350080174110204200801741102059008017411020660080174110214100801741102158008017411021720080174110218900801741102196

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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