Zenith Flex G32182Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002321820), received between Jun 12, 2018 and Jul 16, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2019Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2013 THE PATIENT WAS TREATED FOR AN ASYMPTOMATIC ANEURYSM WITH A MAXIMUM DIAMETER OF 5.3CM. ACCESS WAS OBTAINED THROUGH A CUT-DOWN, WITH AN ABDOMINAL AORTIC STENT GRAFT, MAIN BODY EXTENSION AND BILATERAL LEGS BEING PLACED. THE NECK QUALITY AND SHAPE CLASSIFICATION WAS PARALLEL WITH PARTIAL OCCLUSION FROM PLAQUE/THROMBUS. ADDITIONAL INTERVENTIONS INCLUDED PLACEMENT OF A COVERED STENT IN THE RIGHT ILIAC ARTERY DUE TO A TYPE I ENDOLEAK. THERE WAS NO DIFFICULTY DEPLOYING THE DEVICES, AND WERE FOUND TO BE INTACT AND PATENT WITH NO KINKS OR ENDOLEAKS AT THE END OF THE PROCEDURE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2019. POST-PROCEDURE ECHO-DOPPLER IMAGING PERFORMED ON (B)(6) 2019 FOUND THE DEVICES TO BE INTACT AND PATENT, WITH NO EVIDENCE OF KINKS, ENDOLEAKS OR MIGRATION. FOLLOW UP IMAGING VIA ECHO-DOPPLER ON (B)(6) 2014 AND CT SCAN ON (B)(6) 2015 FOUND THE DEVICES TO BE INTACT AND PATENT, WITH NO EVIDENCE OF STENOSIS, MIGRATION OR KINKS. A TYPE II ENDOLEAK WAS NOTED ON BOTH OCCURRENCES. THIRD AND FOURTH YEAR FOLLOW UP IMAGING WAS NOT COMPLETED. ON (B)(6) 2018, THE PATIENT UNDERWENT A SECONDARY INTERVENTION TO TREAT TYPE I AND TYPE III ENDOLEAKS, WHICH INCLUD

  Patient problems: No Code Available

  MAUDE report 8793828 ↗
• MalfunctionJun 12, 2018Material Frayed; Failure to Advance

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO PLACE A ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION TO PREVENT FURTHER ENLARGEMENT OF THE ANEURYSM. THE DEVICE WAS ADVANCED FROM THE RIGHT FEMORAL ARTERY, BUT IT BECAME CAUGHT ON THE DISTAL SIDE OF THE PREVIOUSLY PLACED LEG GRAFT AND WOULD NOT ADVANCE. THE WIRE WAS THEN REPLACED WITH A STIFFER ONE, BUT THE DELIVERY SYSTEM STILL WOULD NOT ADVANCE, SO IT WAS REMOVED FROM THE PATIENT. THE USER THEN FOUND THAT THE TIP OF THE DELIVERY SHEATH WAS FRAYED. THE TIP WAS MANUALLY AMENDED AND REINSERTED FROM THE LEFT SIDE, BUT IT STILL FAILED TO ADVANCE. THIS PART OF THE PROCEDURE WAS ABANDONED, BUT THE REST OF THE PROCEDURE WAS COMPLETED WITH A COIL EMBOLIZATION OF THE LEFT INTERNAL ILIAC ARTERY AND PLACEMENT OF ANOTHER STENT GRAFT IN THE EXTERNAL ILIAC ARTERY. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7593639 ↗