Events

Recall of Device Recall AFX Endovascular AAA System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Endologix.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76256
  • Event Risk Class
    Class 2
  • Event Number
    Z-1048-2017
  • Event Initiated Date
    2017-01-04
  • Event Date Posted
    2017-01-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152594
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, endovascular graft, aortic aneurysm treatment - Product Code MIH
  • Reason
    Endologix updated information on the rates of type iii endoleaks and suggestions for patient surveillance and treatment.
  • 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.

Device

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

Manufacturer

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