The Recall Desk

FDA (Devices) recall action 76256

Endologix recalled 2 products on 2017-01-25

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
2017-01-25
Critical
0
Units
866

Why these products were recalled

Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.

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.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2017-01-25

    Endologix AFX2 Endovascular AAA System Recall for Updated Endoleak Information

    Endologix is recalling the AFX2 Endovascular AAA System to provide updated information regarding Type III endoleak rates and patient surveillance.

    Product
    AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-80/I20-40 F00820-06 BEA28-120/I16-40 F00820-07 BEA28-100/I16-40 F00820-08 BEA28-80/I16-40 F00820-09 BEA28-60/I16-40 F00820-16 BEA28-110/I20
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2017-01-25

    Endologix AFX Endovascular AAA System Recall for Updated Endoleak Information

    Endologix is recalling 34 units of the AFX Endovascular AAA System to provide updated information regarding Type III endoleak rates and patient surveillance.

    Product
    AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C80 V f00553 I1616/C55F SA F00556 I2013/C70F SA F00
    Category
    Distribution
    1 state