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 14/140/120
Check against the official notice below — it lists the full affected range.
Bard Peripheral Vascular Inc. is recalling the VENOVO Venous Stent System 9F due to reports that the proximal end of the stent does not immediately expand upon deployment and may remain connected to the delivery system. The affected products include multiple product codes (VENEL, VENEM, VENUL, and VENUM series in various sizes) distributed worldwide to the United States and numerous countries including Canada, European nations, Australia, and many others. A total of 23,029 devices were distributed, with 16,582 in the U.S. and 6,447 outside the U.S.
The specific U.S. device serial numbers affected are listed in the recall notice and range from ANEP2484 through ANEQ4998. The source document does not specify a remedy for affected consumers.
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=23,029 (U.S.=16,582; O.U.S. =6,447) Lot/code info: Product Code/GTIN: VENEL14040 /00801741102295; VENEL14060 /00801741102301; VENEL14080 /00801741102318; VENEL14100 /00801741102325; VENEL14120 /00801741102332; VENEL14140 /00801741102349; VENEL14160 /00801741102356; VENEM14040 /00801741102226; VENEM14060 /00801741102233; VENEM14080 /00801741102240; VENEM14100 /00801741102257; VENEM14120 /00801741102264; VENEM14140 /00801741102271; VENEM14160 /00801741102288; VENUL14040 /00801741103483; VENUL14060 /00801741103490; VENUL14080 /00801741103506; VENUL14100 /00801741103513; VENUL14120 /00801741103520; VENUL14140 /00801741103537; VENUL14160 /00801741103544; VENUM14040 /00801741103414; VENUM14060 /00801741103421; VENUM14080 /00801741103438; VENUM14100 /00801741103445; VENUM14120 /00801741103452; VENUM14140 /00801741103469; VENUM14160 /00801741103476; U.S. Device Serial Numbers: ANEP2484; ANEP2485; ANEP2487; ANEP3962; ANEP3964; ANEP3966; ANEP3968; ANEP3972; ANEP3973; ANEP3979; ANEP3982; ANEP3986; ANEP5357; ANEP5362; ANEP5363; ANEP5364; ANEP5367; ANEP5368; ANEP5370; ANEP5373; ANEP5375; ANEP5378; ANEQ0213; ANEQ0216; ANEQ0217; ANEQ0219; ANEQ0220; ANEQ0221; ANEQ1381; ANEQ1382; ANEQ1383; ANEQ1384; ANEQ1402; ANEQ1403; ANEQ1404; ANEQ1405; ANEQ1406; ANEQ1407; ANEQ1408; ANEQ1409; ANEQ1410; ANEQ1411; ANEQ2758; ANEQ2759; ANEQ2777; ANEQ2778; ANEQ3075; ANEQ3076; ANEQ4080; ANEQ4081; ANEQ4082; ANEQ4083; ANEQ4092; ANEQ4093; ANEQ4094; ANEQ4106; ANEQ4387; ANEQ4747; ANEQ4748; ANEQ4749; ANEQ4752; ANEQ4981; ANEQ4982; ANEQ4983; ANEQ4984; ANEQ4985; ANEQ4998;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.