The Recall Desk

FDA (Devices) recall action 94700

Maquet Cardiovascular, LLC recalled 2 products on 2024-07-03

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
2024-07-03
Critical
0
Units
467,223

Why these products were recalled

Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.

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)··2024-07-03

    Endoscopic Vessel Harvesting System Recalled Due to Potential Cautery Malfunction

    Maquet Cardiovascular recalls VasoView HemoPro 2 vessel harvesting systems due to potential fluid ingress that may prevent or unintentionally activate cautery function. The recall affects 430,037 units distributed worldwide.

    Product
    The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001. The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting Systems are designed for use in
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-07-03

    VASOVIEW HemoPro harvesting system fluid ingress may disable cautery

    Maquet Cardiovascular recalls VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems due to fluid ingress into the harvesting tool handle, which may prevent necessary cautery or cause unintended cautery during surgical procedures.

    Product
    The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizin
    Category
    Distribution
    0 states