Devices

Device Recall AFX Endovascular AAA System

  • Model / Serial
    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
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • 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 Description
    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
  • Manufacturer
    Endologix
  • 1 Event

Manufacturer

Endologix
  • Manufacturer Address
    Endologix, 35 Hammond, Irvine CA 92618-1607
  • Manufacturer Parent Company (2017)
    Endologix Inc.
  • Source
    USFDA

6 devices with a similar name

Learn more about the data here

Device Recall AFX Endovascular AAA System, Endoleak Type IIIA
  • Model / Serial
    The correction is not lot specific. It applies to AFX procedures conducted after June 2013
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Distribution and to the countries of : Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey and United Kingdom.
  • Product Description
    AFX Endovascular AAA System, Endoleak Type IIIA
  • Manufacturer
    Endologix
Device Recall AFX Endovascular AAA System
  • Model / Serial
    The correction is not lot specific. It applies to AFX procedures conducted after July 2015
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
  • Product Description
    AFX 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).
  • Manufacturer
    Endologix
Device Recall AFX Endovascular AAA System
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US, and worldwide: Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom.
  • Product Description
    AFX Endovascular AAA System, Endoleak Type IIIB || Common Name: AFX Bifurcated and Accessory Stent Grafts || Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
  • Manufacturer
    Endologix
Device Recall AFX Endovascular AAA System, Endoleak Type IIIB
  • Model / Serial
    The correction is not lot specific. It applies to AFX procedures conducted after July 2015
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US and worldwide: Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom.
  • Product Description
    AFX 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).
  • Manufacturer
    Endologix
Device Recall AFX Endovascular AAA System
  • Model / Serial
    The correction is not lot specific. It applies to AFX procedures conducted after October 2015
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US and worldwide: Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom.
  • Product Description
    AFX 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).
  • Manufacturer
    Endologix
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