Endologix Inc. said the U.S. Food and Drug Administration determined that its AFX Strata heart devices, recalled in July, could lead to serious adverse health consequences or death.
The FDA issued a Class I recall, the most serious of the three class designations used to determine health hazard. The agency said the stent devices were associated with type 3 endoleaks, which are holes, defects or separations in the stent-graft material.
The Irvine, Calif.-based medical device maker noted that the recall did not apply to its AFX Duraply and AFX2 products because they use a different technology.
Endologix had requested all remaining AFX Strata devices be returned from the field and emphasized that it had not manufactured AFX Strata grafts since 2014.
In an Oct. 5 statement, Endologix CEO John Onopchenko said the AFX Strata product was removed from global inventory in the first half of 2017.