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
Check against the official notice below — it lists the full affected range.
Bard Peripheral Vascular Inc. is recalling the Venovo Venous Stent System 10F due to reports that the proximal end of the stent does not immediately expand upon deployment and remains connected to the delivery system. The affected devices were distributed worldwide, including throughout the United States and numerous international locations. A total of 57,515 devices have been recalled, comprising 46,878 units in the U.S. and 10,637 units overseas.
The recall encompasses multiple product codes and configurations of the Venovo stent system with various dimensions, all identified by their specific product codes and GTINs. Consumers or healthcare providers who have received these devices should consult the recall notice for the complete list of affected product codes and lot information. 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=57,515 (U.S.=46,878; O.U.S.=10,637) Lot/code info: Product Code/GTIN: VENEL16040 /00801741102431; VENEL16060 /00801741102448; VENEL16080 /00801741102455; VENEL16100 /00801741102462; VENEL16120 /00801741102479; VENEL16140 /00801741102486; VENEL16160 /00801741102493; VENEL18040 /00801741102578; VENEL18060 /00801741102585; VENEL18080 /00801741102592; VENEL18100 /00801741102608; VENEL18120 /00801741102967; VENEL18140 /00801741102974; VENEL18160 /00801741102981; VENEL20040 /00801741103063; VENEL20060 /00801741103070; VENEL20080 /00801741103087; VENEL20100 /00801741103094; VENEL20120 /00801741103100; VENEL20140 /00801741103117; VENEL20160 /00801741103124; VENEM16040 /00801741102363; VENEM16060 /00801741102370; VENEM16080 /00801741102387; VENEM16100 /00801741102394; VENEM16120 /00801741102400; VENEM16140 /00801741102417; VENEM16160 /00801741102424; VENEM18040 /00801741102509; VENEM18060 /00801741102516; VENEM18080 /00801741102523; VENEM18100 /00801741102530; VENEM18120 /00801741102547; VENEM18140 /00801741102554; VENEM18160 /00801741102561; VENEM20040 /00801741102998; VENEM20060 /00801741103001; VENEM20080 /00801741103018; VENEM20100 /00801741103025; VENEM20120 /00801741103032; VENEM20140 /00801741103049; VENEM20160 /00801741103056; VENUL16040 /00801741103629; VENUL16060 /00801741103636; VENUL16080 /00801741103643; VENUL16100 /00801741103650; VENUL16120 /00801741103667; VENUL16140 /00801741103674; VENUL16160 /00801741103681; VENUL18040 /00801741103766; VENUL18060 /00801741103773; VENUL18080 /00801741103780; VENUL18100 /0080174110379
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.