FDA recall Z-1897-2021

Bard Peripheral Vascular Inc · Class II · device

Product

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 OUS VENEL16160 Venovo 10F 16/160/1200mm OUS VENEL18040 Venovo 10F 18/40/1200mm OUS VENEL18060 Venovo 10F 18/60/1200mm OUS VENEL18080 Venovo 10F 18/80/1200mm OUS VENEL18100 Venovo 10F 18/100/1200mm OUS VENEL18120 Venovo 10F 18/120/1200mm OUS VENEL18140 Venovo 10F 18/140/1200mm OUS VENEL18160 Venovo 10F 18/160/1200mm OUS VENEL20040 Venovo 10F 20/40/1200mm OUS VENEL20060 Venovo 10F 20/60/1200mm OUS VENEL20080 Venovo 10F 20/80/1200mm OUS VENEL20100 Venovo 10F 20/100/1200mm OUS VENEL20120 Venovo 10F 20/120/1200mm OUS VENEL20140 Venovo 10F 20/140/1200mm OUS VENEL20160 Venovo 10F 20/160/1200mm OUS VENEM16040 Venovo 10F 16/40/800mm OUS VENEM16060 Venovo 10F 16/60/800mm OUS

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, 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

Key facts

Status
Ongoing
Initiation date
2020-12-14
Report date
2021-06-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tempe, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1897-2021