Bard Peripheral Vascular Inc recalls VENOVO Venous Stent System 9F models with serial numbers starting with ANE... due to reports of stent not expanding immediately after deployment and remaining connected to delivery system. Affected units include specific model codes and serial numbers listed in the recall notice.
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Bard Peripheral Vascular Inc has recalled certain VENOVO Venous Stent Systems 9F models (with specific model codes and serial numbers) because reports indicate the stent may not expand properly when deployed and stays connected to the delivery system. This could lead to improper placement and potential complications.
The hazard involves the stent not expanding immediately after deployment and remaining connected to the delivery system. This could result in improper placement, potentially causing complications such as blockages or inadequate blood flow in the treated area.
Patients who have received the recalled VENOVO Venous Stent System 9F models (specifically those with model codes like VENEL14040, VENEL14060, etc. and serial numbers starting with ANE) are most at risk. Healthcare providers using these devices for procedures are also affected.
Check if your device has model codes like VENEL14040, VENEL14060, VENEL14080, VENEL14100, VENEL14120, VENEL14140, VENEL14160, VENEM14040, VENEM14060, or VENUL14040, VENUL14060, etc. Serial numbers starting with ANE (e.g., ANEP2484, ANEP2485) also indicate affected units.
Verify your device's model code (e.g., VENEL14040, VENEL14060) or serial number (e.g., ANEP2484) to confirm if it's affected.
Reach out to your doctor or healthcare provider to discuss the recall and potential next steps for affected devices.
Reports indicate the stent may not expand immediately after deployment and remains connected to the delivery system, which could lead to improper placement and potential complications.
Check the model code (e.g., VENEL14040, VENEL14060) or serial number (e.g., ANEP2484) listed in the recall notice.
No action is required if your device is not listed in the recall notice.
We’ve drafted a message you can send Bard Peripheral Vascular Inc to request your refund or repair — edit it as you like.
Subject: Recall Z-1899-2021 — Bard Peripheral Vascular Inc Bard Peripheral Vascular Inc Hello, I own a Bard Peripheral Vascular Inc that is covered by recall Z-1899-2021 from Bard Peripheral Vascular Inc. 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.
