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Class 2 Device Recall AFX Endovascular AAA System |
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| Date Initiated by Firm |
January 04, 2017 |
| Date Posted |
January 19, 2017 |
| Recall Status1 |
Terminated 3 on April 28, 2017 |
| Recall Number |
Z-1048-2017 |
| Recall Event ID |
76256 |
| PMA Number |
P040002 |
| Product Classification |
System, endovascular graft, aortic aneurysm treatment - Product Code MIH
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| 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 |
| Code Information |
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 |
Recalling Firm/
Manufacturer |
Endologix
35 Hammond
Irvine CA 92618-1607
|
Manufacturer Reason
for Recall |
Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance
and treatment.
|
FDA Determined
Cause 2 |
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. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| PMA Database |
PMAs with Product Code = MIH and Original Applicant = Endologix, LLC
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