The Recall Desk

FDA (Devices) recall action 80812

Endologix recalled 4 products on 2018-10-10

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2018-10-10
Critical
0
Units
132,774

Why these products were recalled

Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an existing AFX device. This is a follow-up notification to the one that was sent out in December 2016. The updates are related to the observation of Type III endoleaks.

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

1–4 of 4

  • SevereFDA (Devices)··2018-10-10

    Endologix AFX2 Bifurcated Endograft System Recall for Type III Endoleaks

    Endologix is notifying physicians about the AFX2 Bifurcated Endograft System due to observed Type III endoleaks. This is a follow-up to a December 2016 notification.

    Product
    ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF: BEA22-120/I20-40, BEA22-100/I20-40, BEA22-80/I20-40, BEA22-60/I20-40, BEA22-40/I20-40, BEA22-120/I16-40, BEA22-100/I16-40, BEA22-80/I16-40…
    Category
    Distribution
    52 states
  • SevereFDA (Devices)··2018-10-10

    Endologix AFX Endograft Recall for Type III Endoleak Surveillance

    Endologix is notifying physicians of updated surveillance recommendations for AFX endografts due to observed Type III endoleaks.

    Product
    ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, AFX Proximal Accessory, Infrarenal Model #/REF: A22-22/C55, A22-22/C75, A22-22/C95, A25-25/C55, A25-25/C75, A25-25/C95, A28-28/C55, A28-28/C75…
    Category
    Distribution
    52 states
  • SevereFDA (Devices)··2018-10-10

    Endologix AFX Endovascular AAA System Recall for Type III Endoleaks

    Endologix is notifying physicians of surveillance recommendations for the AFX Endovascular AAA System due to observed Type III endoleaks.

    Product
    ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF: BA22-120/I20-40, BA22-100/I20-40, BA22-80/I20-40, BA22-60/I20-40, BA22-40/I20-40, BA22-120/I16-40, BA22-100/I16-40…
    Category
    Distribution
    52 states
  • SevereFDA (Devices)··2018-10-10

    Endologix AFX Limb Extension Endograft Recall for Type III Endoleaks

    Endologix is notifying physicians of surveillance recommendations for AFX Limb Extension Endografts due to observed Type III endoleaks.

    Product
    ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model #/REF: I16-16/C55, I16-16/C55F, I16-16/C88, I20-13/C70F, I20-13/C88F, I16-16/C55, I16-16/C55F, I16-16/C88, I20-13/C70F, I20-13/C88F; AFX…
    Category
    Distribution
    52 states