# FDA recall Z-1898-2021

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

## Product

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/

## 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-1898-2021
- **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-1898-2021

## Citation

> AI Analytics. FDA recall Z-1898-2021. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-1898-2021. Source: US FDA. Licensed CC0.

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