PlainRecalls
ModerateClass IIOngoing

FDA Devices recall · Reported June 23, 2021

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/

Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.

Recall #
Z-1897-2021
Affected scope
Total Devices=57,515 (U.S.=46,878; O.U.S.=10,637)
Initiated
December 14, 2020
Compiled from official public sources by the publisher.
Verify with FDA Devices →
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Bard Peripheral Vascular Inc recalled VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL16040 Venovo … - a moderate-severity action.

VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL16040 Venovo … was recalled by Bard Peripheral Vascular Inc in June 23, 2021. Reason: Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to…. Check the official notice for the remedy. Verify recall #Z-1897-2021 with the FDA Devices before acting.

The recall

Bard Peripheral Vascular Inc issued this moderate-severity FDA Devices recall-Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to….

Moderate
severity level
Class II
classification
June 23, 2021
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1897-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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 VENEM16080 Venovo 10F 16/80/800mm OUS VENEM16100 Venovo 10F 16/100/800mm OUS VENEM16120 Venovo 10F 16/120/800mm OUS VENEM16140 Venovo 10F 16/140/800mm OUS VENEM16160 Venovo 10F 16/160/800mm OUS VENEM18040 Venovo 10F 18/40/800mm OUS VENEM18060 Venovo 10F 18/60/800mm OUS VENEM18080 Venovo 10F 18/80/800mm OUS VENEM18100 Venovo 10F 18/100/800mm OUS VENEM18120 Venovo 10F 18/120/800mm OUS VENEM18140 Venovo 10F 18/140/800mm OUS VENEM18160 Venovo 10F 18/160/800mm OUS VENEM20040 Venovo 10F 20/40/800mm OUS VENEM20060 Venovo 10F 20/60/800mm OUS VENEM20080 Venovo 10F 20/80/800mm OUS VENEM20100 Venovo 10F 20/100/800mm OUS VENEM20120 Venovo 10F 20/120/800mm OUS VENEM20140 Venovo 10F 20/140/800mm OUS VENEM20160 Venovo 10F 20/160/800mm OUS VENUL16040 Venovo 10F 16/40/1200mm US VENUL16060 Venovo 10F 16/60/1200mm US VENUL16080 Venovo 10F 16/80/1200mm US VENUL16100 Venovo 10F 16/100/1200mm US VENUL16120 Venovo 10F 16/120/1200mm US VENUL16140 Venovo 10F 16/140/1200mm US VENUL16160 Venovo 10F 16/160/1200mm US VENUL18040 Venovo 10F 18/40/1200mm US VENUL18060 Venovo 10F 18/60/1200mm US VENUL18080 Venovo 10F 18/80/1200mm US VENUL18100 Venovo 10F 18/100/1200mm US VENUL18120 Venovo 10F 18/120/1200mm US VENUL18140 Venovo 10F 18/140/1200mm US VENUL18160 Venovo 10F 18/160/1200mm US VENUL20040 Venovo 10F 20/40/1200mm US VENUL20060 Venovo 10F 20/60/1200mm US VENUL20080 Venovo 10F 20/80/1200mm US VENUL20100 Venovo 10F 20/100/1200mm US VENUL20120 Venovo 10F 20/120/1200mm US VENUL20140 Venovo 10F 20/140/1200mm US VENUL20160 Venovo 10F 20/160/1200mm US VENUM16040 Venovo 10F 16/40/800mm US VENUM16060 Venovo 10F 16/60/800mm US VENUM16080 Venovo 10F 16/80/800mm US VENUM16100 Venovo 10F 16/100/800mm US VENUM16120 Venovo 10F 16/120/800mm US VENUM16140 Venovo 10F 16/140/800mm US VENUM16160 Venovo 10F 16/160/800mm US VENUM18040 Venovo 10F 18/40/800mm US VENUM18060 Venovo 10F 18/60/800mm US VENUM18080 Venovo 10F 18/80/800mm US VENUM18100 Venovo 10F 18/100/800mm US VENUM18120 Venovo 10F 18/120/800mm US VENUM18140 Venovo 10F 18/140/800mm US VENUM18160 Venovo 10F 18/160/800mm US VENUM20040 Venovo 10F 20/40/800mm US VENUM20060 Venovo 10F 20/60/800mm US VENUM20080 Venovo 10F 20/80/800mm US VENUM20100 Venovo 10F 20/100/800mm US VENUM20120 Venovo 10F 20/120/800mm US VENUM20140 Venovo 10F 20/140/800mm US VENUM20160 Venovo 10F 20/160/800mm US

Reason for recall

Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Ongoing
Recall number Z-1897-2021
Date reported June 23, 2021
Date initiated December 14, 2020
Recalling firm Bard Peripheral Vascular Inc
Firm location Tempe, AZ
Affected scope Total Devices=57,515 (U.S.=46,878; O.U.S.=10,637)
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, FINL…

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-1897-2021) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼
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 VENEM16080 Venovo 10F 16/80/800mm OUS VENEM16100 Venovo 10F 16/100/800mm OUS VENEM16120 Venovo 10F 16/120/800mm OUS VENEM16140 Venovo 10F 16/140/800mm OUS VENEM16160 Venovo 10F 16/160/800mm OUS VENEM18040 Venovo 10F 18/40/800mm OUS VENEM18060 Venovo 10F 18/60/800mm OUS VENEM18080 Venovo 10F 18/80/800mm OUS VENEM18100 Venovo 10F 18/100/800mm OUS VENEM18120 Venovo 10F 18/120/800mm OUS VENEM18140 Venovo 10F 18/140/800mm OUS VENEM18160 Venovo 10F 18/160/800mm OUS VENEM20040 Venovo 10F 20/40/800mm OUS VENEM20060 Venovo 10F 20/60/800mm OUS VENEM20080 Venovo 10F 20/80/800mm OUS VENEM20100 Venovo 10F 20/100/800mm OUS VENEM20120 Venovo 10F 20/120/800mm OUS VENEM20140 Venovo 10F 20/140/800mm OUS VENEM20160 Venovo 10F 20/160/800mm OUS VENUL16040 Venovo 10F 16/40/1200mm US VENUL16060 Venovo 10F 16/60/1200mm US VENUL16080 Venovo 10F 16/80/1200mm US VENUL16100 Venovo 10F 16/100/1200mm US VENUL16120 Venovo 10F 16/120/1200mm US VENUL16140 Venovo 10F 16/140/1200mm US VENUL16160 Venovo 10F 16/160/1200mm US VENUL18040 Venovo 10F 18/40/1200mm US VENUL18060 Venovo 10F 18/60/1200mm US VENUL18080 Venovo 10F 18/80/1200mm US VENUL18100 Venovo 10F 18/100/1200mm US VENUL18120 Venovo 10F 18/120/1200mm US VENUL18140 Venovo 10F 18/140/1200mm US VENUL18160 Venovo 10F 18/160/1200mm US VENUL20040 Venovo 10F 20/40/1200mm US VENUL20060 Venovo 10F 20/60/1200mm US VENUL20080 Venovo 10F 20/80/1200mm US VENUL20100 Venovo 10F 20/100/1200mm US VENUL20120 Venovo 10F 20/120/1200mm US VENUL20140 Venovo 10F 20/140/1200mm US VENUL20160 Venovo 10F 20/160/1200mm US VENUM16040 Venovo 10F 16/40/800mm US VENUM16060 Venovo 10F 16/60/800mm US VENUM16080 Venovo 10F 16/80/800mm US VENUM16100 Venovo 10F 16/100/800mm US VENUM16120 Venovo 10F 16/120/800mm US VENUM16140 Venovo 10F 16/140/800mm US VENUM16160 Venovo 10F 16/160/800mm US VENUM18040 Venovo 10F 18/40/800mm US VENUM18060 Venovo 10F 18/60/800mm US VENUM18080 Venovo 10F 18/80/800mm US VENUM18100 Venovo 10F 18/100/800mm US VENUM18120 Venovo 10F 18/120/800mm US VENUM18140 Venovo 10F 18/140/800mm US VENUM18160 Venovo 10F 18/160/800mm US VENUM20040 Venovo 10F 20/40/800mm US VENUM20060 Venovo 10F 20/60/800mm US VENUM20080 Venovo 10F 20/80/800mm US VENUM20100 Venovo 10F 20/100/800mm US VENUM20120 Venovo 10F 20/120/800mm US VENUM20140 Venovo 10F 20/140/800mm US VENUM20160 Venovo 10F 20/160/800mm US. Recalled by Bard Peripheral Vascular Inc. Units affected: Total Devices=57,515 (U.S.=46,878; O.U.S.=10,637).
Why was this product recalled? ▼
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 23, 2021. Severity: Moderate. Recall number: Z-1897-2021.
Where was the recalled product distributed? ▼
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.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Methodology · Corrections · Archive as of August 2026