Recall Record

Irvine, CA, United States

Endologix recalls

2 recalls recorded since 2018, most recently on 6 May 2020. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)2

Terminated Class I Medical devices

Recall started
6 May 2020
Terminated
3 May 2024
Reason
A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Polymer leaks may occur during implantation of abdominal stent graft system. Clinical events related to polymer leaks may be systemic and/or aneurysm related.
Distribution
Worldwide DIstribution: U.S (nationwide).: PA, AZ, NY, FL, HI, CA, OR, IL, MS, AR, WI, KY, TX, TN, MO, NJ, MA, MT, VA, MI, CO, WV, NC, NH, NV, CT, ME, WY, OH, OK, IN, UT, AL, WA, GA, SC, KS, LA, NM, MD, DC, NE, SD, RI, IA, VT, ND. and Countries of:: Argentina, Australia, Chile, Hong Kong, Japan, Mal
Initiated
Voluntary: Firm initiated
Recall number
Z-2263-2020

Terminated Class I Medical devices

Recall started
31 July 2018
Terminated
9 April 2024
Reason
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.
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, So
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0008-2019, Z-0006-2019, Z-0007-2019, Z-0009-2019

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.