| Class 1 Device Recall ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft | |
Date Initiated by Firm | July 31, 2018 |
Date Posted | October 03, 2018 |
Recall Status1 |
Terminated 3 on April 09, 2024 |
Recall Number | Z-0008-2019 |
Recall Event ID |
80812 |
PMA Number | P040002S060 P040002S061 |
Product Classification |
System, endovascular graft, aortic aneurysm treatment - Product Code MIH
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Product | ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO,
AFX Proximal Accessory,
Infrarenal Model #/REF:
A22-22/C55,
A22-22/C75,
A22-22/C95,
A25-25/C55,
A25-25/C75,
A25-25/C95,
A28-28/C55,
A28-28/C75,
A28-28/C95,
A31-31/C80,
A31-31/C100,
A34-34/C80,
A34-34/C100;
Suprarenal Model #/REF:
A22-22/C55-O20,
A22-22/C75-O20,
A22-22/C95-O20,
A25-25/C55-O20,
A25-25/C75-O20,
A25-25/C95-O20,
A28-28/C55-O20,
A28-28/C75-O20,
A28-28/C95-O20,
A31-31/C80-O20,
A31-31/C100-O20,
A34-34/C80-O20,
A34-34/C100-O20;
AFX Vela,
Infrarenal Model #/REF:
A22-22/C55V,
A22-22/C75V,
A22-22/C95V,
A25-25/C55V,
A25-25/C75V,
A25-25/C95V,
A28-28/C55V,
A28-28/C75V,
A28-28/C95V,
A31-31/C80V,
A31-31/C100V,
A34-34/C80V,
A34-34/C100V;
Suprarenal Model #/REF:
A22-22/C55-O20V,
A22-22/C75-O20V,
A22-22/C95-O20V,
A25-25/C55-O20V,
A25-25/C75-O20V,
A25-25/C95-O20V,
A28-28/C55-O20V,
A28-28/C75-O20V,
A28-28/C95-O20V,
A31-31/C80-O20V,
A31-31/C100-O20V,
A34-34/C80-O20V,
A34-34/C100-O20V |
Code Information |
All lots distributed from 03/2011 to present. |
Recalling Firm/ Manufacturer |
Endologix 35 Hammond Irvine CA 92618-1607
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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.
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Quantity in Commerce | 56503 |
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 |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database | PMAs with Product Code = MIH
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