Maquet Cardiovascular is recalling 38,648 units of the Vasoview Hemopro Endoscopic Vessel Harvesting System, specifically models VH-3000-W and VH-3500. These surgical devices are used to harvest blood vessels for bypass surgeries, but they may contain polyimide particulate matter (small plastic debris) on the system. This debris could be accidentally introduced into a patient's arteries during coronary artery bypass graft (CABG) or peripheral bypass graft surgery, which could lead to serious medical complications.
The presence of polyimide particulate matter in the surgical field can result in the debris being introduced into the patient's arterial conduit. This poses a risk of blocking blood flow (embolism), inflammation, or other vascular complications during or after heart or limb bypass surgeries.
Manufacturer Notification and Instructions
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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