The Recall Desk

Manufacturer

Endologix, Inc.

2 recalls in our database name Endologix, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
1
Most recent
2020-06-17

Of the 2 recalls from Endologix, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (50%) 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.

1–2 of 2

  • SevereFDA (Devices)·Z-2263-2020·2020-06-17

    Endologix Ovation iX Abdominal Stent Graft Systems Recalled for Polymer Leak Risk

    Endologix is recalling Ovation iX Abdominal Stent Graft Systems because a material weakness may cause polymer leaks during implantation, potentially leading to clinical events.

    Product
    Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, TV-AB2980-J, TV-AB3480-I, TV-AB3480-J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1436-2013·2013-06-19

    Endologix AFX Introducer System Recalled for Dilator Breakage

    Endologix Inc. is voluntarily recalling 53 units of the AFX Introducer System due to reports of dilator breakage during clinical procedures.

    Product
    Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize b
    Category
    Medical Device
    Distribution
    Distributed nationwide