The Recall Desk

Hazard

Endoleak recalls

8 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
8
Critical
0
Severe
1
Most recent
2021-03-17

Of the 8 endoleak recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (13%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all endoleak recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–8 of 8

  • SevereFDA (Devices)·Z-1201-2021·2021-03-17

    Medtronic Recalls Valiant Navion Thoracic Stent Grafts Due to Structural Defects

    Medtronic is recalling 33,430 Valiant Navion Thoracic Stent Graft Systems worldwide due to endoleaks, stent fractures, and ring enlargement.

    Product
    Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0007-2019·2018-10-10

    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
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0008-2019·2018-10-10

    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, A2
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0009-2019·2018-10-10

    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
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0006-2019·2018-10-10

    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
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1543-2017·2017-03-29

    Medtronic Recalls Endurant Bifurcated Stent Grafts Due to Fabric Permeability

    Medtronic is voluntarily recalling specific Endurant and Endurant II bifurcated stent graft systems because fabric permeability variations may be associated with endoleaks during initial implant procedures.

    Product
    Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E ETBF2513C166E ETBF2313C166E ETBF2316C166E ETBF2313C124E ETBF2513C145E ETBF2516C124E ETBF2316C124E ETBF2513C124E. Cardiology:
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1048-2017·2017-01-25

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1049-2017·2017-01-25

    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
    Medical Device
    Distribution
    Distributed nationwide