Recall Register

Endologix: FDA recalls

FDA enforcement reports name Endologix as the recalling firm in 8 events. The events have 12 product records. The recalls started from 2016 to 2018. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

8 events, newest first.

FDA enforcement events of Endologix
InitiatedProduct (first record)TypeClassRecordsStatus
31 Jul 2018ENDOLOGIX 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, BA22-80/I16-40, BA22-60/I16-40, BA22-40/I16-40, BA22-120/I13-40, BA22-100/I13-40, BA22-80/I13-40, BA22-60/I13-40,…DeviceClass I4Terminated
4 Jan 2017AFX 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 F00555 I2020/C55F SA F00558 IS2025/C55 SA F00559 IS2025/C65 SA F0072605 A2525/C75O20 V F0072606 A2525/C95O20 V f00552 I1616/C88 SA F00557 I2013/C88F SA The…DeviceClass II2Terminated
27 Dec 2016AFX 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).DeviceClass II1Terminated
27 Dec 2016AFX 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).DeviceClass II1Terminated
27 Dec 2016AFX Endovascular AAA System, Endoleak Type IIIADeviceClass II1Terminated
27 Dec 2016AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm TreatmentDeviceClass II1Terminated
27 Dec 2016AFX 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 abdominal aortic or aortoiliac aneurysms (AAA).DeviceClass II1Terminated
27 Dec 2016AFX 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 abdominal aortic or aortoiliac aneurysms (AAA).DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Endologix: events for each product type
TypeEvents
Device8
Endologix: events in each class
ClassEvents
Class II7
Class I1
Share of the events of the firm in Class I
13%
Share of all events on the register in Class I
18%
Events with the status Ongoing
0

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Endologix, by the year that the recall started. The largest year is 2016, with 6 events.

Official channels

Cite this page

Recall Register. Endologix: FDA recalls. https://recallregister.com/firm/endologix/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
CA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Endologix have?
Class II: 7 events. Class I: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Endologix?
FDA event 80812, which the firm started on 31 Jul 2018. The first product in the record is: 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, BA22-80/I16-40, BA22-60/I16-40, BA22-40/I16-40, BA22-120/I13-40, BA22-100/I13-40, BA22-80/I13-40, BA22-60/I13-40,…
How many FDA recalls of Endologix have the status Ongoing?
No event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.