ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF: BEA22-120/I20-40, BEA22-100/I2

FDA device recall Z-0007-2019 · posted 2018-10-03 · Terminated

Recall details

Recalling firm

Endologix

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 taken

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.

Root cause

Device Design

Status

Terminated

Product code

MIH

Quantity affected

13178

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

Date initiated

2018-07-31

Date posted

2018-10-03

Date terminated

2024-04-09

Location

Irvine, CA