ModerateClass IITerminated

FDA Devices recall · Reported January 25, 2017

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/I20-30 F00820-17 BEA28-90/I20-30 F00820-18 BEA28-70/I20-30 F00820-20 BEA28-110/I16-30 F00820-21 BEA28-90/I16-30 F00820-22 BEA28-70/I16-30 F00820-28 BEA25-120/I20-40 F00820-29 BEA25-100/I20-40 F00820-30 BEA25-80/I20-

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on January 25, 2017. Severity: Moderate. Recall number: Z-1049-2017.

Q: Where was the recalled product distributed?

Distribution: Worldwide Distribution - US (nationwide)and Internationally to Austria, Belgium, France, Germany, Greece, Italy, Ireland, Monaco, Poland Portugal, Romania, Spain, Sweden, Turkey, Israel, Argentina, Florida, Mexico, Chile, Brazil, Japan, Singapore, Malaysia, and Thailand..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-1049-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.

Recall #: Z-1049-2017
Affected scope: 832 units
Initiated: January 4, 2017

Compiled from official public sources by the editorial team. · Updated July 2026

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Endologix recalled AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-4… - a moderate-severity action.

AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-4… was recalled by Endologix in January 25, 2017. Reason: Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance an…. Check the official notice for the remedy. Verify recall #Z-1049-2017 with the FDA Devices before acting.

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The recall

Endologix issued this moderate-severity FDA Devices recall-Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance an….

Moderate
severity level: 832 units
affected scope: Class II
classification: January 25, 2017
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1049-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1049-2017) was formally reported on January 25, 2017, with the manufacturer initiating the action on January 4, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Endologix is listed as the recalling firm, operating out of Irvine, CA. Federal records list the affected scope as 832 units.

The documented reason for this recall is: Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment. Distribution data in the federal record shows the product reached: Worldwide Distribution - US (nationwide)and Internationally to Austria, Belgium, France, Germany, Greece, Italy, Ireland, Monaco, Poland Portugal, Romania, Spain, Sweden, Turkey, Israel, Argentina, Florida, Mexico, Chil…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

832 units

Related Recalls

3 from same agency

Product description

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/I20-30 F00820-17 BEA28-90/I20-30 F00820-18 BEA28-70/I20-30 F00820-20 BEA28-110/I16-30 F00820-21 BEA28-90/I16-30 F00820-22 BEA28-70/I16-30 F00820-28 BEA25-120/I20-40 F00820-29 BEA25-100/I20-40 F00820-30 BEA25-80/I20-40 F00820-43 BEA25-110/I20-30 F00820-44 BEA25-90/I20-30 F00820-45 BEA25-70/I20-30 F00820-57 BEA22-80/I20-40 F00820-71 BEA22-90/I20-30 F00820-72 BEA22-70/I20-30 The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA

Reason for recall

Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1049-2017
Date reported	January 25, 2017
Date initiated	January 4, 2017
Recalling firm	Endologix
Firm location	Irvine, CA
Affected scope	832 units
Distribution	Worldwide Distribution - US (nationwide)and Internationally to Austria, Belgium, France, Germany, Greece, Italy, Ireland, Monaco, Poland Portugal, Romania, Spain, Sweden, Turkey, Israel, Argentina, Florida, Mexico, Chile, Brazil, Japan, Si…

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

832 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1049-2017) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on January 25, 2017. Severity: Moderate. Recall number: Z-1049-2017.

Where was the recalled product distributed? ▼

Distribution: Worldwide Distribution - US (nationwide)and Internationally to Austria, Belgium, France, Germany, Greece, Italy, Ireland, Monaco, Poland Portugal, Romania, Spain, Sweden, Turkey, Israel, Argentina, Florida, Mexico, Chile, Brazil, Japan, Singapore, Malaysia, and Thailand..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-1049-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 25, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.