The Recall Desk

FDA (Devices) recall action 71998

Maquet Cardiovascular Us Sales, Llc recalled 2 products on 2015-11-18

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
2015-11-18
Critical
0
Units
—

Why these products were recalled

Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Part Number 1007.28A0) in conjunction with Universal Frame (Part Number 1007.24F0) for lumbar spine surgery. The hip elements may have a negative effect on patients- venous backflow under certain conditions and may have been a contributing factor to thromboembolic events.

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

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2015-11-18

    Maquet Adjustable Positioning Elements Recalled Due to Thromboembolic Events

    Maquet is recalling Adjustable Positioning Elements used in spine surgery after two serious thromboembolic events were reported.

    Product
    Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany. Patient positioners. The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and
    Category
    Distribution
    3 states
  • SevereFDA (Devices)··2015-11-18

    Maquet Universal Frame Recalled Due to Thromboembolic Event Reports

    Maquet is recalling Universal Frames and Adjustable Positioning Elements after two serious thromboembolic events were reported during lumbar spine surgery.

    Product
    Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after surgical
    Category
    Distribution
    3 states