Zenith Flex G48462Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002484624), received between Sep 23, 2019 and Sep 23, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT AFTER AN ENDOVASCULAR AORTIC REPAIR PROCEDURE, A HOLE IN A ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG WAS DISCOVERED UPON EXPLANT. THE DEVICE HAD BEEN PREVIOUSLY IMPLANTED IN AN (B)(6) MALE PATIENT WITH A PRE-EXISTING ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2011. AFTER THE ENDOGRAFT WAS PLACED, THE ANEURYSM SAC REPORTEDLY CONTINUED TO GROW, WHICH LEAD TO THE NEED FOR AN ADDITIONAL PROCEDURE. COIL EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY WAS PERFORMED IN (B)(6) 2013. FOLLOWING IN (B)(6) 2015, A DIRECT SAC PUNCTURE WAS PERFORMED WITH GLUE EMBOLIZATION. IN (B)(6) 2018, A TYPE II EMBOLIZATION WAS UNSUCCESSFULLY ATTEMPTED. THERE WAS NO EVIDENCE OF A TYPE I OR TYPE III ENDOLEAK AT THAT TIME. THE DEVICE WAS ULTIMATELY EXPLANTED VIA THE ABDOMEN ON (B)(6) 2019, IN WHICH A HOLE IN THE GRAFT WAS REVEALED. THIS PROCEDURE WAS ACCOMPANIED BY AN OPEN ANEURYSM REPAIR. IT WAS REPORTED THAT BALLOONING WAS DONE AT THE TOP SEALING STENT OF THE TFFB, AS WELL AS THE FULL LENGTH OF THE LIMBS, INCLUDING THE OVERLAP. NO PORTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT. NO ADDITIONAL ADVERSE EFFECTS HAVE BEEN REPORTED AT THE TIME OF THIS REPORT. IMAGING WILL BE PROVIDED TO THE M

  Patient problems: No Code Available

  MAUDE report 9105154 ↗