Product Description
ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model #/REF:
I16-16/C55,
I16-16/C55F,
I16-16/C88,
I20-13/C70F,
I20-13/C88F,
I16-16/C55,
I16-16/C55F,
I16-16/C88,
I20-13/C70F,
I20-13/C88F;
AFX Stand Alone
I16-16/C55 SA,
I16-16/C55F SA,
I16-16/C88 SA,
I20-13/C70F SA,
I20-13/C88F SA,
I20-20/C55 SA,
I20-20/C55F SA,
IS20-25/C55 SA,
IF20-25/C65 SA,
IS20-25/C65 SA
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.
Action Details
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.
Distribution Pattern
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
Code Information / Serial Numbers
All lots distributed from 03/2011 to present.