FDA-Device2021-06-23Class II
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 10/140/1200mm OUS; VENEL10160 /Venovo 8F10/160/1200mm OUS; VENEL12040 /Venovo 8F 12/40/1200mm OUS; VENEL12060 /Venovo 8F 12/60/1200mm OUS; VENEL12080 /Venovo 8F 12/80/1200mm OUS; VENEL12100 /Venov
Bard Peripheral Vascular Inc
Hazard
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Sold states
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, PORTUGAL, ROMANIA, RUSSIA, SAUDIA ARABIA, SINGAPORE, SLOVAKIA (SLOVAK REPUBLIC), SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES (UAE), UNITED KINGDOM, VIETNAM
Affected count
Total Devices=12,258 (U.S.= 7,234; O.U.S.=5,024)
Manufactured in
1625 W 3rd St Bldg 1, Tempe, AZ, United States
Products
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 10/140/1200mm OUS; VENEL10160 /Venovo 8F10/160/1200mm OUS; VENEL12040 /Venovo 8F 12/40/1200mm OUS; VENEL12060 /Venovo 8F 12/60/1200mm OUS; VENEL12080 /Venovo 8F 12/80/1200mm OUS; VENEL12100 /Venovo 8F 12/100/1200mm OUS; VENEL12120 /Venovo 8F 12/120/1200mm OUS; VENEL12140 /Venovo 8F 12/140/1200mm OUS; VENEL12160 /Venovo 8F 12/160/1200mm OUS; VENEM10040 /Venovo 8F 10/40/800mm OUS; VENEM10060 /Venovo 8F 10/60/800mm OUS; VENEM10080 /Venovo 8F 10/80/800mm OUS; VENEM10100 /Venovo 8F 10/100/800mm OUS; VENEM10120 /Venovo 8F 10/120/800mm OUS; VENEM10140 /Venovo 8F 10/140/800mm OUS; VENEM10160 /Venovo 8F 10/160/800mm OUS; VENEM12040 /Venovo 8F 12/40/800mm OUS; VENEM12060 /Venovo 8F 12/60/800mm OUS; VENEM12080 /Venovo 8F 12/80/800mm OUS; VENEM12100 /Venovo 8F 12/100/800mm OUS; VENEM12120 /Venovo 8F 12/120/800mm OUS; VENEM12140 /Venovo 8F 12/140/800mm OUS; VENEM12160 /Venovo 8F 12/160/800mm OUS; VENUL10040 /Venovo 8F 10/40/1200mm US; VENUL10060 /Venovo 8F 10/60/1200mm US; VENUL10080 /Venovo 8F 10/80/1200mm US; VENUL10100 /Venovo 8F 10/100/1200mm US; VENUL10120 /Venovo 8F 10/120/1200mm US; VENUL10140 /Venovo 8F 10/140/1200mm US; VENUL10160 /Venovo 8F 10/160/1200mm US; VENUL12040 /Venovo 8F 12/40/1200mm US; VENUL12060 /Venovo 8F 12/60/1200mm US; VENUL12080 /Venovo 8F 12/80/1200mm US; VENUL12100 /Venovo 8F 12/100/1200mm US; VENUL12120 /Venovo 8F 12/120/1200mm US; VENUL12140 /Venovo 8F 12/140/1200mm US; VENUL12160 /Venovo 8F 12/160/1200mm US; VENUM10040 /Venovo 8F 10/40/800mm US; VENUM10060 /Venovo 8F 10/60/800mm US; VENUM10080 /Venovo 8F 10/80/800mm US; VENUM10100 /Venovo 8F 10/100/800mm US; VENUM10120 /Venovo 8F 10/120/800mm US; VENUM10140 /Venovo 8F 10/140/800mm US; VENUM10160 /Venovo 8F 10/160/800mm US; VENUM12040 /Venovo 8F 12/40/800mm US; VENUM12060 /Venovo 8F 12/60/800mm US; VENUM12080 /Venovo 8F 12/80/800mm US; VENUM12100 /Venovo 8F 12/100/800mm US; VENUM12120 /Venovo 8F 12/120/800mm US; VENUM12140 /Venovo 8F 12/140/800mm US; VENUM12160 /Venovo 8F 12/160/800mm US;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1898-2021Don't want to check this manually?
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