Bard is recalling VENOVO Venous Stent Systems 10F models with serial numbers listed in the notice due to reports of the stent not expanding properly after deployment, which could cause complications during medical procedures.
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Bard is recalling specific models of VENOVO Venous Stent Systems 10F because they may not expand properly after deployment, potentially causing complications during medical procedures. Affected units have unique serial numbers listed in the recall notice.
The stent may not expand immediately upon deployment and remain connected to the delivery system, which could lead to complications during medical procedures. This issue is reported but does not typically cause serious injury in normal use.
Patients who have received the recalled VENOVO Venous Stent Systems 10F models during medical procedures are most at risk. Healthcare providers using these devices for procedures are also affected.
Check the product's serial number against the list of affected serial numbers provided in the recall notice. The affected models include VENOVO 10F with specific dimensions and product codes listed in the notice.
Compare your device's serial number with the list of affected serial numbers provided in the recall notice.
The affected models are VENOVO Venous Stent Systems 10F with specific dimensions and product codes listed in the recall notice, including VENEL16040 through VENUL20160 and other variants.
Check your device's serial number against the list of affected serial numbers provided in the recall notice.
Contact Bard Peripheral Vascular Inc directly to confirm if your device is affected and follow their instructions for next steps.
We’ve drafted a message you can send Bard to request your refund or repair — edit it as you like.
Subject: Recall Z-1897-2021 — Bard Bard Hello, I own a Bard that is covered by recall Z-1897-2021 from Bard. 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.
