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U.S. Department of Health and Human Services

Class 1 Device Recall ENDOLOGIX AFX Endovascular AAA System

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  Class 1 Device Recall ENDOLOGIX AFX Endovascular AAA System see related information
Date Initiated by Firm July 31, 2018
Date Posted October 03, 2018
Recall Status1 Open3, Classified
Recall Number Z-0006-2019
Recall Event ID 80812
PMA Number P040002S060 P040002S061 
Product Classification System, endovascular graft, aortic aneurysm treatment - Product Code MIH
Product ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF:
BA22-120/I20-40,
BA22-100/I20-40,
BA22-80/I20-40,
BA22-60/I20-40,
BA22-40/I20-40,
BA22-120/I16-40,
BA22-100/I16-40,
BA22-80/I16-40,
BA22-60/I16-40,
BA22-40/I16-40,
BA22-120/I13-40,
BA22-100/I13-40,
BA22-80/I13-40,
BA22-60/I13-40,
BA22-40/I13-40,
BA22-110/I20-30,
BA22-90/I20-30,
BA22-70/I20-30,
BA22-50/I20-30,
BA22-110/I16-30,
BA22-90/I16-30,
BA22-70/I16-30,
BA22-50/I16-30,
BA22-100/I20-55,
BA22-80/I20-55,
BA22-100/I16-55,
BA22-80/I16-55,
BA25-120/I20-40,
BA25-100/I20-40,
BA25-80/I20-40,
BA25-60/I20-40,
BA25-40/I20-40,
BA25-120/I16-40,
BA25-100/I16-40,
BA25-80/I16-40,
BA25-60/I16-40,
BA25-40/I16-40,
BA25-120/I13-40,
BA25-100/I13-40,
BA25-80/I13-40,
BA25-60/I13-40,
BA25-40/I13-40,
BA25-110/I20-30,
BA25-90/I20-30,
BA25-70/I20-30,
BA25-50/I20-30,
BA25-110/I16-30,
BA25-90/I16-30,
BA25-70/I16-30,
BA25-50/I16-30,
BA25-100/I20-55,
BA25-80/I20-55,
BA25-100/I16-55,
BA25-80/I16-55,
BA28-120/I20-40,
BA28-100/I20-40,
BA28-80/I20-40,
BA28-60/I20-40,
BA28-40/I20-40,
BA28-120/I16-40,
BA28-100/I16-40,
BA28-80/I16-40,
BA28-60/I16-40,
BA28-40/I16-40,
BA28-120/I13-40,
BA28-100/I13-40,
BA28-80/I13-40,
BA28-60/I13-40,
BA28-40/I13-40,
BA28-110/I20-30,
BA28-90/I20-30,
BA28-70/I20-30,
BA28-50/I20-30,
BA28-110/I16-30,
BA28-90/I16-30,
BA28-70/I16-30,
BA28-50/I16-30,
BA28-100/I20-55,
BA28-80/I20-55,
BA28-100/I16-55,
BA28-80/I16-55
Code Information All lots distributed from 03/2011 to present.
Recalling Firm/
Manufacturer		 Endologix
35 Hammond
Irvine CA 92618-1607
Manufacturer Reason
for Recall		 Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an existing AFX device. This is a follow-up notification to the one that was sent out in December 2016. The updates are related to the observation of Type III endoleaks.
FDA Determined
Cause 2		 Device Design
Action On 07/31/2018, the firm mailed Urgent Important Safety Updates via FedEx ground service with return delivery confirmation. Physicians were informed about the following: 1) Type III endoleak rates, 2) Refined patient-tailored surveillance recommendations, 3) Sizing recommendations, 4) Recommendations for device interventions/ re-interventions. No product return is required. Customers with questions are encouraged to call Customer service 800-983-2284 (5:00 A.M. - 6:00 P.M. Pacific Time). Updated 03/01/2023: Because of the ongoing concerns regarding Type III endoleaks with Endologix AFX Endovascular AAA Graft Systems, the FDA has publicly communicated concerns: https://public4.pagefreezer.com/browse/FDA/21-08-2022T08:51/https:/www.fda.gov/medical-devices/letters-health-care-providers/update-type-iii-endoleaks-associated-endovascular-graft-systems-letter-health-care-providers Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication | FDA (pagefreezer.com) UPDATE: The FDA Reminds Patients and Health Care Providers of the Importance of At Least Yearly, Lifelong Follow-Up with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication | FDA (pagefreezer.com) On November 2, 2021, the FDA convened a public meeting of the CDRH Circulatory System Devices Panel of the Medical Devices Advisory Committee to share information and perspectives from interested parties on the benefit-risk profile of the Endologix AFX endovascular graft system focused on the risk of Type III endoleaks.
Quantity in Commerce 45304
Distribution U.S.: PA, VA, CA, AZ, IN, GA, FL, IL, OK, MN, OH, KY, MS, NC, MI, AL, CT, LA, SC, TN, NY, WI, MD, WV, AR, NV, NJ, TX, CO, NE, NM, MA, IA, AK, OR, ME, SD, MO, MT, KS, DE, WA, UT, NH, ND, DC, RI, HI, WY, ID, VT, PR; Foreign (OUS): Canada, Argentina, Australia, Brazil, CHILE , Hong Kong, Japan, South Korea, Philippines, Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Romania, Spain, Sweden, Switzerland, Turkey, United Kingdom
Total Product Life Cycle TPLC Device Report
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = MIH and Original Applicant = Endologix, LLC
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