Bard Peripheral Vascular Inc recalls VENOVO Venous Stent Systems 8F models with serial numbers starting with ANEQ or ANDU. The stent may not expand properly after deployment, potentially causing complications. Affected units include specific model codes and serial numbers listed in the recall.
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Bard Peripheral Vascular Inc is recalling VENOVO Venous Stent Systems 8F models (specifically VENEL10040 through VENUL12160) due to reports that the stent may not expand properly after deployment. This could lead to complications if the stent remains connected to the delivery system.
The recall reports that the proximal end of the stent may not expand immediately after deployment and could remain connected to the delivery system. This could potentially cause complications during or after the procedure, but the risk is not described as life-threatening in normal use.
Healthcare professionals who use the VENOVO Venous Stent System 8F for medical procedures are most at risk. Patients who have received this stent are not directly affected by the recall but should consult their doctors.
Check if your VENOVO Venous Stent System 8F has a product code starting with VENEL, VENEM, VENUL, or VENUM (e.g., VENEL10040) or a serial number beginning with ANEQ or ANDU (e.g., ANEQ4079).
Review your product's model code (e.g., VENEL10040) and serial number (e.g., ANEQ4079) to confirm if it's affected.
Reach out to Bard Peripheral Vascular Inc directly for guidance on next steps if your product is affected.
Bard reports that the proximal end of the stent may not expand properly after deployment and could remain connected to the delivery system, potentially causing complications.
Patients who received the stent should consult their doctor for advice, as the recall does not directly affect them.
Check your product code (e.g., VENEL10040) and serial number (e.g., ANEQ4079) against the list provided in the recall.
We’ve drafted a message you can send Bard Peripheral Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1898-2021 — Bard Peripheral Vascular Bard Peripheral Vascular Hello, I own a Bard Peripheral Vascular that is covered by recall Z-1898-2021 from Bard Peripheral Vascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
