FDA (Devices) recall action 80812
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Endologix is notifying physicians of surveillance recommendations for the AFX Endovascular AAA System due to observed Type III endoleaks.
Endologix is notifying physicians about the AFX2 Bifurcated Endograft System due to observed Type III endoleaks. This is a follow-up to a December 2016 notification.
Endologix is notifying physicians of updated surveillance recommendations for AFX endografts due to observed Type III endoleaks.
Endologix is notifying physicians of surveillance recommendations for AFX Limb Extension Endografts due to observed Type III endoleaks.