# FDA recall Z-1897-2021

> **Bard Peripheral Vascular Inc** · Class II · device recall initiated 2020-12-14.

## 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

- **Recall number:** Z-1897-2021
- **Recalling firm:** Bard Peripheral Vascular Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-12-14
- **Report date:** 2021-06-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tempe, AZ, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-1897-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1897-2021. Source: US FDA. Licensed CC0.

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