Zenith Flex G48422Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10827002484228), received between Apr 18, 2016 and Oct 11, 2022 — classified as 1 death, 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PATIENT NEEDED AN ADDITIONAL GRAFT AFTER THE PLACEMENT OF A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY. THE PHYSICIAN DISCOVERED A TYPE 3 ENDOLEAK ONE MONTH POST OPERATION DURING A FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN AND ULTRASOUND. THE ENDOLEAK WAS FOUND IN THE "CRUTCH OF THE MAIN BODY." THE ANEURYSM SAC APPEARED TO BE STABLE AND HAD NO INCREASE IN SIZE. THE GRAFTS REMAINED IN SITU AND NO UNINTENDED PART OF THE DEVICE REMAINED INSIDE THE BODY OF THE PATIENT. THE PHYSICIAN HAS ASKED COOK PLANNING SERVICE TO PLAN AN ADDITIONAL GRAFT FOR RELINING. THE PATIENT WAS REPORTED TO BE STABLE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Failure of Implant

  MAUDE report 15578876 ↗
• InjuryJun 25, 2021Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Insufficient Information; Thrombosis/Thrombus

  MAUDE report 12069143 ↗
• InjuryJun 23, 2020Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE TOP CAP OF A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY WAS UNABLE TO BE RELEASED DURING AN AAA PROCEDURE. THE DEVICE WAS INITIALLY PLACED WITH NO ISSUES. THE GRAFT WAS DEPLOYED WITHOUT PROBLEMS, HOWEVER IT WAS REPORTED THAT THE TOP CAP WAS UNABLE TO BE RELEASED. THE USER ATTEMPTED TROUBLESHOOTING TECHNIQUES WITHOUT SUCCESS. THE PHYSICIAN CONVERTED TO AN OPEN REPAIR TO REMOVE THE DEPLOYED TFFB DEVICE. IT WAS LATER REPORTED THAT THE DISTAL TRIGGER WIRE WAS RELEASED WITHOUT PROBLEMS PRIOR TO ADVANCING THE TOP CAP, AND THERE WAS NO PROBLEM REMOVING THE PROXIMAL TRIGGER WIRE. DURING TROUBLESHOOTING, THE PHYSICIAN WAS ABLE TO REMOVE ALL TRIGGER WIRES WITHOUT PROBLEMS AND THE FIRST CENTIMETER OF TOP CAP ADVANCEMENT WAS SUCCESSFUL, UNTIL IT COULD NOT BE ADVANCED FURTHER. THE PHYSICIAN ATTEMPTED TO ADVANCE WITH MILD FORCE BUT WAS UNABLE, AS MORE FORCE WOULD HAVE CAUSED THE INNER CANNULA TO KINK. AFTER OPENING THE PATIENT, THE PARTIALLY DEPLOYED GRAFT WAS EXPLANTED BY CUTTING THE INNER CANNULA. AN ATTEMPT TO REMOVE THE TOP CAP OUTSIDE OF THE BODY WAS COMPLETED WITH "EXTREME FORCE". THE PHYSICIAN THEN STOPPED TO ENABLE AN INVESTIGATION. THE POSITION OF T

  Patient problems: No Code Available

  MAUDE report 10186226 ↗
• InjuryMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Code Available; Thrombus

  MAUDE report 8596492 ↗
• MalfunctionJan 31, 2019Fluid/Blood Leak; Fluid/Blood Leak

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8294798 ↗
• InjuryOct 30, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE FOLLOWING DEVICES WERE IMPLANTED ON (B)(6) 2014, WITH CONTINUING ANEURYSM GROWTH. G48422-TFFB-30-82-ZT, LOT 447811 G55239-ZSLE-16-90-ZT, LOT 4247510 G55239-ZSLE-16-90-ZT, LOT 4537245 G32184-ESBE-32-39, LOT 3438589 IN 2017, THEY COILED THE PATIENT'S INFERIOR MESENTERIC ARTERY (IMA) BECAUSE THEY THOUGHT THERE WAS A LEAK. DUE TO PERSISTENT ENDOLEAK, AN OPEN ABDOMINAL AORTIC ANEURYSM REPAIR WAS PERFORMED ON (B)(6) 2018. WHEN THEY OPENED THE ANEURYSM TO EXAMINE THE DEVICE, BLOOD WAS SQUIRTING THROUGH THE SUTURE HOLES OF THE DEVICE. THEY EXPLANTED THE DEVICE. THE COMPLAINT DEVICES WERE DISPOSED OF BY THE CUSTOMER. ADDITIONAL PATIENT, DEVICE AND EVENT DETAILS HAVE BEEN REQUESTED BUT HAVE NOT YET BEEN FORTHCOMING AT THE TIME OF THIS REPORT.

  Patient problems: No Code Available

  MAUDE report 8021511 ↗
• InjuryNov 28, 2016Bent; Bent

  AN EVAR PROCEDURE WAS BEING PERFORMED ON THE (B)(6) YEAR OLD MALE PATIENT. WHEN RETRIEVING THE TOP CAP, THE SUPRARENAL STENT GOT CAUGHT AND BENT. THE USER HAD TO CONVERT TO AN AUI AND USED 2 ADDITIONAL DEVICES TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 6128995 ↗
• MalfunctionOct 12, 2016Difficult or Delayed Positioning; Difficult or Delayed Positioning

  NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6020022 ↗
• DeathApr 18, 2016Device Expiration Issue; Device Expiration Issue

  THE PATIENT ARRIVED TO THE EMERGENCY ROOM WITH A RUPTURED ABDOMINAL AORTA. IT WAS DECIDED THAT THEY WERE GOING TO TRY AND PERFORM AN ENDOVASCULAR PROCEDURE IN ORDER TO SAVE THE PATIENT¿S LIFE. THE PATIENT CODED WHILE IN THE ER AND WAS IMMEDIATELY TRANSPORTED TO THE OR. IN THE OR IT WAS DETERMINED THAT THE GRAFT NEEDED FOR THE REPAIR HAD AN EXPIRED DATE, BUT THEY FELT IT WAS STILL THE PATIENTS ONLY OPTION AT THE TIME SO IT WAS IMPLANTED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT SURVIVE THE PROCEDURE DUE TO THE MASSIVE AMOUNT OF INTERNAL BLEEDING FROM THE RUPTURED AORTA.

  Patient problems: Death

  MAUDE report 5584649 ↗