Maquet recalls Vasoview Hemopro VH-3500 endoscopic vessel harvesting system due to potential polyimide particles entering arterial grafts during coronary or peripheral bypass surgery.
Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a coronary artery bypass graft (CABG) or peripheral bypass graft surgery.
Maquet is recalling its Vasoview Hemopro VH-3500 endoscopic vessel harvesting system because it may contain polyimide particles that could enter a patient's arterial graft during heart surgery. This poses a risk of potential complications during coronary artery bypass graft (CABG) or peripheral bypass graft procedures.
The system may contain polyimide particulate matter that could be introduced into the arterial conduit during surgery. This could potentially cause complications for patients receiving coronary artery bypass grafts or peripheral bypass grafts.
Patients undergoing coronary artery bypass graft (CABG) or peripheral bypass graft surgery who have the Vasoview Hemopro VH-3500 endoscopic vessel harvesting system. Surgeons and medical facilities using this specific model are most at risk.
Check for the model VH-3500 with UDI-DI numbers listed in the recall notice: 00607567701250 and specific lot numbers including 3000279266 through 3000351187.
Identify the model VH-3500 with UDI-DI numbers listed in the recall notice (00607567701250) and specific lot numbers.
The product may contain polyimide particles that could be introduced into the arterial conduit during surgery, so it is not safe for use without recalling.
The recall notice does not specify a remedy, so you should contact Maquet directly for guidance.
Check for the model VH-3500 with UDI-DI number 00607567701250 and specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-0724-2024 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-0724-2024 from Maquet. 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.
