Z-1048-2017Class II

AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312...

Name: Z-1048-2017 AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312...
Creator: Endologix
Published: 2017-01-04
License: https://open.fda.gov/license/

Endologix LLC / initiated 2017-01-04 / Terminated / root cause: design

FDA source

Endologix began a recall of 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... on 2017-01-04. FDA classified it as Class II and gives the reason as "Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1048-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-04
Posted: 2017-01-19
Terminated: 2017-04-28
Recalling firm: Endologix LLC
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 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 AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Reason for recall: Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.
Root cause tag: design
FDA root cause: Device Design
Action: Endologix sent a Dear Physician letter on 12/30/16 to inform them information related to the AFX Endovascular AAA System (AFX System). The letter provides updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment. Customers were informed of the voluntary recall of the small remaining quantity of original AFX with Strata graft material, and the larger diameter sizes of AFX2. Customers with any questions are instructed to contact their Endologix representative. Customers with questions were instructed to call their Endologix representative. On 1/17/17, Endologix issued a press release to inform consumers that firm is resuming shipments of all sizes of AFX2 Endovascular AAA systems and appointed Laura Nagel as Vice President, Global Quality. Consumers are informed that the large diameter sizes of AFX2 were placed on temporary hold on 12/27/16 to investigate a manufacture issue.
Quantity in commerce: 34 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, Singapore, Malaysia, and Thailand.
Product codes and lots: Lot # Lot/Serial 1164318 1164318019 1164390 1164390020 1164389 1164389009 1164388 1164388021 1262039 1262039002 1246596 1246596024 1164477 1164477026 1164470 1164470015 1055838 1055838026 1055838 1055838022 1250434 1250434002 1249743 1249743025 1257058 1257058017 1055877 1055877010 1249363 1249363009 1249358 1249358025 1267536 1267536008 1047170 1047170016 1267536 1267536025 1257553 1257553020 1214252 1214252011 1229346 1229346007 1274322 1274322003 1257977 1257977011 1250424 1250424016 1250424 1250424008 1250424 1250424007 1250399 1250399024 1047135 1047135007 1275167 1275167014 1275166 1275166031 1274322 1274322023 1250399 1250399011 1056308 1056308054

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1048-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1048-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-19
Z-1049-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-19

Product code MIH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)