The Recall Desk

Manufacturer

Endologix

12 recalls in our database name Endologix as the manufacturing or recalling firm.

What the numbers show

Total
12
Critical
0
Severe
0
Most recent
2018-10-10

Of the 12 recalls from Endologix we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–12 of 12

  • 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-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
  • 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
  • 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-1035-2017·2017-01-25

    Endologix AFX Endovascular AAA System Clinical Data Correction

    Endologix is correcting cumulative clinical data reports for the AFX Endovascular AAA System and Powerlink System. This action applies to procedures conducted after June 2013.

    Product
    AFX Endovascular AAA System, Endoleak Type IIIA
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1038-2017·2017-01-25

    Endologix AFX Endovascular AAA System Instructions for Use Update

    Endologix updated the Instructions for Use for the AFX Endovascular AAA System to address endoleak Type IIIB.

    Product
    AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1037-2017·2017-01-25

    Endologix AFX Endovascular AAA System Instructions for Use Updated

    Endologix updated the Instructions for Use and modified the AFX Endovascular AAA System. The correction applies to procedures conducted after July 2015.

    Product
    AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdomin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1039-2017·2017-01-25

    Endologix AFX Endovascular AAA System Instructions for Use Update

    Endologix is updating the Instructions for Use and implementing modifications to the AFX Endovascular AAA System.

    Product
    AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdomi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1054-2017·2017-01-25

    Endologix Updates Instructions for Use for AFX Endovascular AAA System

    Endologix is recalling 17,139 units of the AFX Endovascular AAA System to update the Instructions for Use and implement device modifications.

    Product
    AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1047-2017·2017-01-25

    Endologix Updates Instructions for Use for AFX Endovascular AAA System

    Endologix is updating the Instructions for Use and making modifications to the AFX Endovascular AAA System. This applies to procedures conducted after October 2015.

    Product
    AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
    Category
    Medical Device
    Distribution
    0 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Endologix LLC

Source: Wikidata (Q140158738), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.