Zenith Flex G48451Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002484518), received between Mar 12, 2018 and Mar 30, 2020 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THERE WAS DIFFICULTY ADVANCING A ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG INTO THE PATIENT. UPON REMOVAL FROM THE PACKAGING, THE DEVICE WAS RINSED PRIOR TO THE PROCEDURE AND IT WAS NOTED THAT THE STAINLESS STEEL SLEEVE AT THE END OF THE GRAFT "WAS NOT SMOOTH". RESISTANCE WAS FELT WHEN REMOVING THE TRIGGER WIRE AND THE OPERATOR ALSO FOUND THAT THE PROXIMAL END OF THE OUTER SHEATH OF THE GRAFT WAS "TWISTED UNEVENLY". THE GRAFT WAS INSERTED INTO THE PATIENT "UNTIL THE TWISTED PART WAS TOUCHED", BUT RESISTANCE WAS FELT DURING ADVANCEMENT. THE PATIENT HAD CALCIFIED AND TORTUOUS VESSELS. THE OPERATOR REMOVED THE GRAFT FROM THE PATIENT AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER COOK ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG, WHICH SUCCESSFULLY REACHED THE TARGET POSITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9898697 ↗
• InjuryOct 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER AN ENDOVASCULAR REPAIR SURGERY ON A (B)(6) MALE PATIENT ON (B)(6) 2016, A LEAKAGE AT THE JUNCTION OF AN AORTIC STENT (ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY) AND A ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG (WHICH IS THE SUBJECT OF THIS REPORT) WAS DISCOVERED ON (B)(6) 2016 VIA AN EMERGENCY ANGIOGRAPHY PERFORMED THROUGH FEMORAL ARTERY PUNCTURE. THE CONTRAST SPECIFICALLY SHOWED LEAKAGE BETWEEN THE IMPLANTED AORTIC STENT AND THE RIGHT ILIAC ARTERY. PRIOR TO THIS, AN ABDOMINAL ULTRASOUND EXAMINATION PERFORMED ON (B)(6) 2016 HAD SUGGESTED A RIGHT PERIRENAL HEMATOMA. TWO STENTS FROM ANOTHER MANUFACTURER WERE IMPLANTED IN THE RIGHT ILIAC ARTERY UPON DISCOVERING THE LEAKAGE. INTRAOPERATIVE ULTRASOUND EXPLORATION SHOWED NO PROGRESSION OF THE RETROPERITONEAL HEMATOMA. THE FEMORAL ARTERY INCISION WAS THEN CLOSED AND THE PATIENT SHOWED STABLE VITAL SIGNS. HOWEVER, THE PATIENT CONTINUED TO HAVE GROSS HEMATURIA AND DECREASED HEMOGLOBIN POST-SURGERY WHICH RESULTED IN ADDITIONAL RENAL AND ILIAC ARTERIOGRAPHIES ON (B)(6) 2016. CONTRAST LEAKAGE WAS DETECTED AT THE RIGHT RENAL ARTERY; CONSEQUENTLY, RENAL ARTERY EMBOLIZATION WAS PERFORMED. FOLLOW

  Patient problems: Hematoma; No Code Available

  MAUDE report 9163603 ↗
• MalfunctionMar 12, 2018Positioning Failure; Positioning Failure

  IT WAS REPORTED DURING THE GRAFT IMPLANTATION IN A (B)(6)-YEAR-OLD, FEMALE PATIENT WITH ABDOMINAL AORTIC ANEURYSM, ONE TFFB-26-96-ZT AND ONE TFLE-12-73-ZT HAD BEEN IMPLANTED SUCCESSFULLY. THE OPERATOR COULD NOT RELEASE THE GRAFT OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG (TFLE-12-90-ZT) AFTER THE OUTER SHEATH WAS WITHDRAWN IN THE SAME SIDE OF THE ILIAC ARTERY. AS REPORTED, THE OPERATION WAS COMPLETED WITH ANOTHER TFLE-12-90-ZT. ACCORDING TO THE REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7330604 ↗