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 10/140/120
Check against the official notice below — it lists the full affected range.
Bard Peripheral Vascular Inc. is recalling the VENOVO Venous Stent System 8F due to reports that the proximal end of the stent does not immediately expand upon deployment and remains connected to the delivery system. A total of 12,258 devices have been distributed worldwide, including 7,234 in the United States and 5,024 outside the U.S., across numerous countries including Canada, Australia, and throughout Europe.
The recall affects multiple product codes across different stent sizes and configurations, each identified by specific GTIN numbers. The source document does not specify what remedy consumers or healthcare providers should pursue regarding the recalled devices.
Written by software from the official notice below. Not reviewed by a lawyer.
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Reason for recall: Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system. Distribution: Worldwide distribution. US Nationwide, ALGERIA, ANDORRA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, BRAZIL, BRUNEI, BULGARIA, CHILE, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK, DEUTSCHLAND, EGYPT, FINLAND, FRANCE, GEORGIA, GREECE, HONG KONG, HUNGARY, INDIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JORDAN, KAZAKHSTAN, MALAYSIA, MEXICO, NETHERLANDS, NORWAY, OMAN, PANAMA, POLAND, PORTUG Quantity: Total Devices=12,258 (U.S.= 7,234; O.U.S.=5,024) Lot/code info: 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 /00801741103254; VENUL10160 /00801741103261; VENUL12040 /00801741103346; VENUL12060 /00801741103353; VENUL12080 /00801741103360; VENUL12100 /00801741103377; VENUL12120 /00801741103384; VENUL12140 /00801741103391; VENUL12160 /00801741103407; VENUM10040 /00801741103131; VENUM10060 /00801741103148; VENUM10080 /00801741103155; VENUM10100 /00801741103162; VENUM10120 /00801741103179; VENUM10140 /00801741103186; VENUM10160 /00801741103193; VENUM12040 /00801741103278; VENUM12060 /00801741103285; VENUM12080 /00801741103292; VENUM12100 /0080174110330
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.