Reported Jun 23, 2021 · Ongoing
VENOVO Venous Stent System 8F Product Description(REF)/dimension
Bard Peripheral Vascular Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bard Peripheral Vascular Inc · 1625 W 3rd St Bldg 1 · Tempe, AZ · 85281-2438
Is this the product you have?
VENOVO Venous Stent System 8F Product Description(REF)/dimension
56 of 56 products
| # | Product as published |
|---|---|
| 1 | VENEL10040 /Venovo 8F 10/40/1200mm OUS |
| 2 | VENEL10060 /Venovo 8F 10/60/1200mm OUS |
| 3 | VENEL10080 /Venovo 8F 10/80/1200mm OUS |
| 4 | VENEL10100 /Venovo 8F 10/100/1200mm OUS |
| 5 | VENEL10120 /Venovo 8F 10/120/1200mm OUS |
| 6 | VENEL10140 /Venovo 8F 10/140/1200mm OUS |
| 7 | VENEL10160 /Venovo 8F10/160/1200mm OUS |
| 8 | VENEL12040 /Venovo 8F 12/40/1200mm OUS |
| 9 | VENEL12060 /Venovo 8F 12/60/1200mm OUS |
| 10 | VENEL12080 /Venovo 8F 12/80/1200mm OUS |
| 11 | VENEL12100 /Venovo 8F 12/100/1200mm OUS |
| 12 | VENEL12120 /Venovo 8F 12/120/1200mm OUS |
| 13 | VENEL12140 /Venovo 8F 12/140/1200mm OUS |
| 14 | VENEL12160 /Venovo 8F 12/160/1200mm OUS |
| 15 | VENEM10040 /Venovo 8F 10/40/800mm OUS |
| 16 | VENEM10060 /Venovo 8F 10/60/800mm OUS |
| 17 | VENEM10080 /Venovo 8F 10/80/800mm OUS |
| 18 | VENEM10100 /Venovo 8F 10/100/800mm OUS |
| 19 | VENEM10120 /Venovo 8F 10/120/800mm OUS |
| 20 | VENEM10140 /Venovo 8F 10/140/800mm OUS |
- Lot codes and dates
2,865 of 2,865 products
Products covered by this recall Model / number Barcodes Product as published VENEL1004000801741102004Product Code/ /00801741102004 — 00801741104664VENEL10060 /00801741104664 — 00801741104671VENEL10080 /00801741104671 — 00801741102035VENEL10100 /00801741102035 — 00801741102042VENEL10120 /00801741102042 — 00801741102059VENEL10140 /00801741102059 — 00801741102066VENEL10160 /00801741102066 — 00801741102141VENEL12040 /00801741102141 — 00801741102158VENEL12060 /00801741102158 — 00801741102172VENEL12080 /00801741102172 — 00801741102189VENEL12100 /00801741102189 — 00801741102196VENEL12120 /00801741102196 — 00801741102202VENEL12140 /00801741102202 — 00801741102219VENEL12160 /00801741102219 — 00801741101939VENEM10040 /00801741101939 — 00801741101946VENEM10060 /00801741101946 — 00801741101953VENEM10080 /00801741101953 — 00801741101960VENEM10100 /00801741101960 — 00801741101977VENEM10120 /00801741101977 — 00801741101984VENEM10140 /00801741101984 - Amount recalled
- Total Devices=12,258 (U.S.= 7,234; O.U.S.=5,024)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- GA
Why it was recalled
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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