Reported Jun 23, 2021 · Ongoing
VENOVO Venous Stent System 9F 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 9F Product Description(REF)/dimension
28 of 28 products
| # | Product as published |
|---|---|
| 1 | VENEL14040 /Venovo 9F 14/40/1200mm OUS |
| 2 | VENEL14060 /Venovo 9F 14/60/1200mm OUS |
| 3 | VENEL14080 /Venovo 9F 14/80/1200mm OUS |
| 4 | VENEL14100 /Venovo 9F 14/100/1200mm OUS |
| 5 | VENEL14120 /Venovo 9F 14/120/1200mm OUS |
| 6 | VENEL14140 /Venovo 9F 14/140/1200mm OUS |
| 7 | VENEL14160 /Venovo 9F 14/160/1200mm OUS |
| 8 | VENEM14040 /Venovo 9F 14/40/800mm OUS |
| 9 | VENEM14060 /Venovo 9F 14/60/800mm OUS |
| 10 | VENEM14080 /Venovo 9F 14/80/800mm OUS |
| 11 | VENEM14100 /Venovo 9F 14/100/800mm OUS |
| 12 | VENEM14120 /Venovo 9F 14/120/800mm OUS |
| 13 | VENEM14140 /Venovo 9F14/140/800mm OUS |
| 14 | VENEM14160 /Venovo 9F 14/160/800mm OUS |
| 15 | VENUL14040 /Venovo 9F 14/40/1200mm US |
| 16 | VENUL14060 /Venovo 9F 14/60/1200mm US |
| 17 | VENUL14080 /Venovo 9F 14/80/1200mm US |
| 18 | VENUL14100 /Venovo 9F 14/100/1200mm US |
| 19 | VENUL14120 /Venovo 9F 14/120/1200mm US |
| 20 | VENUL14140 /Venovo 9F 14/140/1200mm US |
- Lot codes and dates
2,910 of 2,910 products
Products covered by this recall Model / number Barcodes Product as published VENEL1404000801741102295Product Code/ /00801741102295 — 00801741102301VENEL14060 /00801741102301 — 00801741102318VENEL14080 /00801741102318 — 00801741102325VENEL14100 /00801741102325 — 00801741102332VENEL14120 /00801741102332 — 00801741102349VENEL14140 /00801741102349 — 00801741102356VENEL14160 /00801741102356 — 00801741102226VENEM14040 /00801741102226 — 00801741102233VENEM14060 /00801741102233 — 00801741102240VENEM14080 /00801741102240 — 00801741102257VENEM14100 /00801741102257 — 00801741102264VENEM14120 /00801741102264 — 00801741102271VENEM14140 /00801741102271 — 00801741102288VENEM14160 /00801741102288 — 00801741103483VENUL14040 /00801741103483 — 00801741103490VENUL14060 /00801741103490 — 00801741103506VENUL14080 /00801741103506 — 00801741103513VENUL14100 /00801741103513 — 00801741103520VENUL14120 /00801741103520 — 00801741103537VENUL14140 /00801741103537 - Amount recalled
- Total Devices=23,029 (U.S.=16,582; O.U.S. =6,447)
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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Bard Peripheral Vascular Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.