The Recall Desk

FDA (Devices) recall action 93615

Maquet Cardiovascular, LLC recalled 2 products on 2024-01-24

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2024-01-24
Critical
0
Units
38,648

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2024-01-24

    Endoscopic Vessel Harvesting System Recalled Due to Polyimide Particulate Matter Risk

    Maquet Cardiovascular is recalling 38,094 units of the Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500, due to polyimide particulate matter contamination that may be introduced into the arterial conduit during coronary artery bypass or peripheral bypass surgery.

    Product
    Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-01-24

    Endoscopic Vessel Harvesting System Recalled Due to Polyimide Particulate Matter Risk

    Maquet Cardiovascular is recalling the Vasoview Hemopro Endoscopic Vessel Harvesting System (model VH-3000-W) because polyimide particulate matter may be present on the device and could be introduced into arterial conduits during bypass graft surgery.

    Product
    Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .
    Category
    Distribution
    0 states