VENOVO Venous Stent System 8F deployment failure during insertion
The VENOVO Venous Stent System 8F may fail to expand properly upon deployment and remain connected to the delivery system, affecting approximately 12,258 devices worldwide including 7,234 in the United States.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II recall involves a concrete functional defect where the proximal stent end fails to expand properly upon deployment and may remain connected to the delivery system. While no hospitalizations or injuries are reported in the source text, the failure to deploy properly creates a documented risk of harm to patients by preventing effective vascular treatment.
Plain-English summary
The VENOVO Venous Stent System 8F, manufactured by Bard Peripheral Vascular Inc, is being recalled. The product includes 56 different stent configurations across multiple sizes and lengths, distributed worldwide to over 50 countries.
Reports indicate that the proximal end of the stent may not expand properly immediately upon deployment and may remain connected to the delivery system. This functional defect could prevent the stent from reaching its intended treatment site.
The recall encompasses approximately 12,258 devices: 7,234 in the United States and 5,024 internationally. Patients and healthcare providers with affected devices should contact Bard Peripheral Vascular Inc for information about the recall and appropriate management.
The recalled product
- 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…
- Manufacturer
- Bard Peripheral Vascular Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Code/GTIN: VENEL10040 /00801741102004
- VENEL10060 /00801741104664
- VENEL10080 /00801741104671
- VENEL10100 /00801741102035
- VENEL10120 /00801741102042
- VENEL10140 /00801741102059
- VENEL10160 /00801741102066
- VENEL12040 /00801741102141
- VENEL12060 /00801741102158
- VENEL12080 /00801741102172
- VENEL12100 /00801741102189
- VENEL12120 /00801741102196
- VENEL12140 /00801741102202
- VENEL12160 /00801741102219
- VENEM10040 /00801741101939
- VENEM10060 /00801741101946
- VENEM10080 /00801741101953
- VENEM10100 /00801741101960
- VENEM10120 /00801741101977
- VENEM10140 /00801741101984
Distribution
Part of a larger recall action
This product is one of 3 recalled by Bard Peripheral Vascular Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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