Zenith Flex G48428Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10827002484280), received between Aug 28, 2014 and Apr 7, 2022 — classified as 10 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2022Failure to Advance; Failure to Advance

  ADDITIONAL INFORMATION PROVIDED ON 12APR2022. THE ENDOVASCULAR AORTIC REPAIR PROCEDURE WAS ABANDONED. THE PATIENT WAS SENT TO SURGERY. THE PATIENT IS NOW DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14046287 ↗
• InjuryMay 6, 2021Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED AN (B)(6) PATIENT HAD A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY IMPLANTED "RECENTLY" FOR AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) AND ILIAC BRAND-GRAFT DEVICE (IBD) PROCEDURE. THE PHYSICIAN REPORTED THERE IS WHAT HE BELIEVES TO BE A TYPE III ENDOLEAK ABOVE THE GRAFT BIFURCATION, HOWEVER THE EXACT LOCATION OF THE LEAK IS DIFFICULT TO IDENTIFY ON THE CT SCAN. AN ADDITIONAL PROCEDURE WAS COMPLETED BY INSERTING TWO 12 MM PTA BALLOONS INTO THE LIMBS OF THE FLEX GRAFT. ANGIOGRAPHY REVEALED A LEAK IN THE BODY OF THE GRAFT. A PROCEDURE TO RELINE USING A BODY EXTENSION GRAFT IS BEING DISCUSSED BUT HAS CURRENTLY NOT BEEN SCHEDULED. NO OTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11783100 ↗
• InjuryNov 5, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT TWO HOLES WERE FOUND IN A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY FOLLOWING IMPLANTATION. THE DEVICE WAS INITIALLY IMPLANTED IN 2014. FOLLOWING, THEY WERE COMPLIANT WITH "SOME FOLLOW UP" INITIALLY, BUT WAS "LOST TO FOLLOW UP AS OF THE LAST FEW YEARS". THE PATIENT PRESENTED TO THE HOSPITAL WITH AN UNSTABLE RUPTURED ABDOMINAL ANEURYSM, PROMPTING THE PHYSICIAN TO REPAIR THE TWO HOLES IN THE GRAFT THROUGH AN OPEN PROCEDURE BY SEWING THEM. NO DEVICES WERE EXPLANTED AND THE PATIENT HAS BEEN REPORTED TO BE "DOING WELL/GREAT AFTER THE PROCEDURE". ADDITIONAL INFORMATION REGARDING THE PATIENT AND DEVICE HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Code Available; Rupture

  MAUDE report 10792915 ↗
• InjuryOct 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Code Available

  MAUDE report 9194069 ↗
• MalfunctionJun 12, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8692035 ↗
• InjuryOct 8, 2018Malposition of Device; Activation, Positioning or Separation Problem; Malposition of Device; Activation, Positioning or Separation Problem

  THERE HAS BEEN NO NEW EVENT INFORMATION RECEIVED.

  Patient problems: No Code Available

  MAUDE report 7943027 ↗
• MalfunctionFeb 19, 2018Leak/Splash; Leak/Splash

  IT HAS BEEN REPORTED THE FEMALE PATIENT HAD A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY IMPLANTED IN 2014. THE PATIENT HAS PRESENTED WITH A SUSPECTED TYPE III ENDOLEAK. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME; HOWEVER, ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING DETAILS OF THE INITIAL PROCEDURE AND THE PATIENT'S CONDITION.

  Patient problems: No Code Available

  MAUDE report 7280842 ↗
• MalfunctionDec 29, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT UPON OPENING THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY IN THE STERILE FIELD, THE PHYSICIAN NOTICED WHAT APPEARS TO BE A HAIR STUCK IN THE PEEL AWAY. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7154937 ↗
• InjuryJul 17, 2017Failure to Advance; Device Operates Differently Than Expected; Failure to Advance; Device Operates Differently Than Expected

  IT WAS REPORTED THAT AN ENDOVASCULAR GRAFT EXCLUSION WAS BEING PERFORMED ON AN (B)(6) MALE PATIENT WHO HAD A TORTUOUS ANATOMY AND AN ABDOMINAL AORTIC ANEURYSM. THE WHOLE LENGTH OF THE SHEATH WAS ALREADY IN THE PATIENT'S BODY, ACCORDING TO OPERATION PROCESS. THE USER WAS ABLE TO PASS THE DEVICE OVER THE ULTRA-HARD WIRE GUIDE WITHOUT ANY DIFFICULTY, AS IT WAS VERY SMOOTH; HOWEVER, WHEN THE WHOLE LENGTH OF THE SHEATH WAS IN THE PATIENT'S BODY, THE DEVICE BOUNCED BACK. (THE DEVICE WAS NOT DAMAGED, KINKED OR BENT PRIOR TO USE ON THE PATIENT). THE STENT GRAFT FAILED TO REACH THE DESIRED POSITION.(THE PROXIMAL MARKERS NEED TO REACH THE LOWER EDGE OF THE 2ND LUMBAR VERTEBRA, HOWEVER THE PROXIMAL MARKERS ON THE MAIN BODY STENTGRAFT CAN ONLY REACH THE UPPER EDGE OF THE 4TH LUMBAR VERTEBRA, THE DIFFERENCE IS 6 CENTIMETERS). THIS RESULTED IN THE OPERATION BEING INTERRUPTED FOR AN HOUR. THE PHYSICIAN PLACED ANOTHER MANUFACTURER'S PRODUCT TO FINISH THE PROCEDURE SUCCESSFULLY. THE CUSTOMER COMPLAINED THAT THERE WAS A STENTGRAFT DESIGN DEFECT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6717412 ↗
• MalfunctionJul 13, 2017Device Operates Differently Than Expected

  UPON ATTEMPTING TO REMOVE THE DEPLOYMENT SYSTEM, AFTER SUCCESSFUL ENDOVASCULAR AORTIC REPAIR, IT WAS CATCHING ON THE GRAFT. THE GRAFT REMAINED IN THE PATIENT AS INTENDED, THERE WERE NO ADDITIONAL PROCEDURES AS A RESULT OF THE DIFFICULTY AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS FROM THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6711978 ↗
• InjuryJun 14, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE (B)(6) MALE PATIENT HAD AN ENDOVASCULAR GRAFT EXCLUSION(EVGE) PROCEDURE DUE TO AN ABDOMINAL AORTIC ANEURYSM (AAA). DEPLOYING OF THE MAINBODY STENT WAS SMOOTH. AFTER THE MAINBODY STENT GRAFT WAS DEPLOYED INSIDE THE AAA , DURING THE CTA , THE PHYSICIANS FOUND THE BLOOD FLOW INSIDE THE CONTRALATERAL BIFURCATION TO BE SIGNIFICANTLY SLOWER THAN THE BLOOD FLOW ON THE OPPOSITE SIDE. AT THE SAME TIME, IT WAS OBSERVED VIA X-RAY FLUOROSCOPY THAT THERE WAS AN UNKNOWN OBJECT (POLYESTER, METAL, SUTURE) IN THE STENT. THE DIRECTOR USED BALLOON FOR EXPANSION, BUT WAS UNSUCCESSFUL IN EXPANDING THE STENT. THE DIRECTOR DECIDED TO IMPLANT ONE BARE STENT, THEN PERFORMED THE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA). BLOOD FLOW IMPROVED, BUT DID NOT TOTALLY SOLVE THE PROBLEM. THE PHYSICIAN FURTHER REPORTED, THEY WERE NOT ABLE TO REMOVE THE UNKNOWN "OBJECT." MEDICAL RECORDS PROVIDED 25 MAY 2016 REPORTED THE PATIENTS PRE-OPERATIVE NOTES AND APPROVAL FROM THE FAMILY FOR THE PHYSICIAN TO PERFORM "ENDOVASCULAR EXCLUSION OF ABDOMINAL AORTIC ANEURYSM , PRE-EXISTING INFORMATION ADDED TO OTHER RELEVANT HISTORY. POST-OPERATIVE AND SURGICAL NOTES WERE NOT INCLUDED IN THE MEDICAL REPORT. ACCORDING TO THE INITIAL RE

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 5722973 ↗
• InjuryFeb 23, 2016Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  DURING DEPLOYMENT, THE TOP CAP OF DELIVERY SYSTEM COULD NOT BE PUSHED UP. A LOT OF FORCE HAD TO BE USED TO RELEASE IT AND IT DID FINALLY GIVE AND BE PUSHED UP. LATER, DURING THE PROCEDURE, THE DOCTOR NOTICED THAT THE Z-STENTS (METAL) ON THE GRAFT WAS STICKING OUT AT AN UNUSUAL ANGLE ON THE RIGHT HAND SIDE BUT THOUGHT NOTHING OF IT. THE DOCTOR THEN COMPLETED THE EVAR AND DID A CONTRAST RUN TO CHECK EVERYTHING WAS OK. A LEAK WAS NOTED AND SO THE DOCTOR BALLOONED THE GRAFT TO ATTEMPT TO STOP THE LEAK. IN DOING THIS, THE DOCTOR MANAGED TO MAKE THE LEAK BIGGER SOMEHOW AND BELIEVES THAT THERE WAS A TEAR IN THE FABRIC OF THE GRAFT WHICH WAS MADE WORSE WITH THE BALLOONING AND WHICH THEN LED TO A SIGNIFICANT LEAK. UNFORTUNATELY, WHEN THE DOCTOR BALLOONED THE GRAFT INITIALLY, SHE ALSO MANAGED TO RUPTURE THE ANEURYSM WHICH PUT THE PATIENT AT CONSIDERABLE RISK. THE DOCTOR THEN HAD TO USE A FURTHER GRAFT TO SEAL THE RIP IN THE FABRIC AND STOP THE LEAK. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AFTER THIS OCCURRENCE.

  Patient problems: No Code Available; Rupture

  MAUDE report 5453501 ↗
• InjuryFeb 17, 2016Leak/Splash; Leak/Splash

  DURING THE AAA EVAR, ABDOMINAL PROCEDURE ON THE (B)(6) YEAR OLD MALE PATIENT, AFTER DEPLOYMENT OF THE MAIN BODY OF THE ZENITH FLEX GRAFT, THE DILATOR AND INNER ASSEMBLY WERE REMOVED. IT WAS NOTED THAT THE CAPTOR VALVE WAS LEAKING AND DID NOT STOP FOR THE REMAINDER OF THE PROCEDURE. THE PATIENT REQUIRED PLATELETS DUE TO THE BLOOD LOSS. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: Blood Loss

  MAUDE report 5442103 ↗
• InjuryJan 20, 2015Activation, Positioning or Separation Problem

  A (B)(6) MALE UNDERWENT AN EVAR ON (B)(6) 2014. A ZENITH FLEX MAIN BODY (1820334-2015-00038) WAS PLACED BY THE PHYSICIAN WITH NO ISSUES. THE CONTRALATERAL GATE WAS ACCESS AND AMPLATZ WIRE PLACED. THE ZENITH ILIAC LEG GRAFT WITH SPIRAL-Z TECHNOLOGY WAS INSERTED AND RESISTANCE WAS MET. THE WIRE WAS REPOSITIONED TWICE AND ATTEMPTED TWO MORE TIMES. THE DECISION WAS MADE TO RETRIEVE THE TOP CAP FROM IPSILATERAL SIDE. THE TRIGGER WIRE WAS RELEASED AND GREY POSITIONER WAS ADVANCED. HALFWAY UP, THE ENTIRE GRAFT MOVED UP ENCROACHING ON RIGHT RENAL AND SMA. A CODA BALLOON WAS INSERTED ON THE CONTRALATERAL SIDE AND THE GRAFT WAS PULLED DOWN AND STRAIGHTENED. THE PHYSICIAN PROCEEDED WITH A THIRD ATTEMPT TO INSERT A NEW ZENITH ILIAC LEG GRAFT WITH SPIRAL-Z TECHNOLOGY (1820334-2015-00054), BUT WAS UNABLE TO FULLY INSERT. THE DECISION WAS MADE TO BRIDGE THE GAP WITH AN ICAST COVERED STENT. SEVERAL ATTEMPTS WERE MADE WITH THE WIRE AND CATHETER TO CANNULATE THE SMA AND RIGHT RENAL ARTERY THAT WERE COVERED WITH NO SUCCESS. FINALLY THE ZENITH ILIAC LEG GRAFT WAS PLACED IN THE IPSILATERAL SIDE. THE GRAFT WAS BALLOONED WITH A CODA AND A FINAL ANGIO WAS PERFORMED. THE SMA WAS OCCLUDED AND PARTIAL RIGHT

  Patient problems: Other (for use when an appropriate patient code cannot be identified)

  MAUDE report 4452604 ↗
• InjuryAug 28, 2014Leak/Splash

  THIS (B)(6) MALE PT IS IN THE (B)(4), HAD A PROXIMAL TYPE I ENDOLEAK AT THE CONCLUSION OF THE DEPLOYMENT PROCEDURE ON (B)(6) 2014. THE PT WAS BEING TREATED FOR A 5.1 CM AORTIC ANEURYSM. THE PROXIMAL NECK HAD AN INVERTED FUNNEL SHAPE WITH PARTIAL PLAQUE/THROMBUS. BOTH ILIAC ARTERIES HAD MILD TORTUOSITY, NO OCCLUSIVE DISEASE, AND NO CALCIFICATION. THE PT RECEIVED A MAIN BODY DEVIC, A LEFT ILIAC LEG, AND A RIGHT ILIAC LEG. THERE WAS NO DIFFICULTY DEPLOYING ANY OF THE DEVICES. NO OTHER DEVICES WERE PLACED AND NO OTHER PROCEDURES WERE PERFORMED. A MOLDING BALLOON WAS USED BUT NO DETAILS WERE PROVIDED REGARDING ITS USE. AT THE CONCLUSION OF THE PROCEDURE, THE DEVICE WERE PATENT WITH NO EXTERNAL COMPRESSION, FLOW-LIMITING KINKS, OR THROMBUS. A PROXIMAL TYPE I ENDOLEAK WAS NOTED. NO FURTHER INFO HAS BEEN RECEIVED SINCE DEVICE DEPLOYMENT.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 4054144 ↗