Zenith Flex G48413Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10827002484136), received between Jan 7, 2015 and Sep 15, 2023 — classified as 10 injuries, 3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2023Difficult to Remove; Obstruction of Flow; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Migration; Difficult to Remove; Obstruction of Flow; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Migration

  ADDITIONAL INFORMATION WAS PROVIDED ON 18SEP2023. AFTER PLACING THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (TFFB-26-96-ZT) AND THE CONTRALATERAL ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-90-ZT, LOT 15554354) THE PHYSICIAN ATTEMPTED TO DOCK THE TOP CAP OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (TFFB-26-96-ZT). HOWEVER, THE PHYSICIAN CAUGHT AN APEX OF THE BARE SUPRA RENAL STENT BETWEEN THE DILATOR AND THE SHEATH OF THE DELIVERY SYSTEM WHILE ATTEMPTING TO DOCK THE TOP CAP. THE PHYSICIAN WAS UNAWARE OF THE STENT BEING CAUGHT AND WAS UNSUCCESSFUL IN HIS ATTEMPT TO REMOVE THE DELIVERY SYSTEM. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE DELIVERY SYSTEM. THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (TFFB-26-96-ZT) MIGRATED UPWARD AND CAUSED OCCLUSION OF THE RENAL ARTERIES. THE CONTRALATERAL ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-90-ZT) SEPARATED FROM THE MAIN BODY GRAFT. THE PHYSICIAN HAD TO CONVERT THE PATIENT TO AN OPEN REPAIR. A PORTION OF THE MAIN BODY GRAFT REMAINED IN THE PATIENT DURING THE OPEN REPAIR.

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 17757051 ↗
• InjuryJul 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TYPE 1A ENDOLEAK OCCURRED ON A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. THE PATIENT WAS ON HEPARIN. THE DEVICE WAS REPORTED TO HAVE BEEN DEPLOYED PER THE INSTRUCTIONS FOR USE (IFU). COMPLETION ANGIOGRAM REVEALED A TYPE 1A ENDOLEAK. IN RESPONSE, A CODA BALLOON WAS RE-INSERTED AND INFLATED IN THE PROXIMAL SEAL ZONE. FOLLOWING, AN ADDITIONAL ANGIOGRAM REVEALED THAT THE ENDOLEAK HAD NOT BEEN RESOLVED, SO IT WAS DECIDED THAT EIGHT COMPETITOR ENDO-ANCHORS WOULD BE PLACED CIRCUMFERENTIALLY AROUND/IN THE PROXIMAL SEAL STENT. A FINAL ANGIOGRAM SHOWED THAT THE ENDOLEAK HAD THEN BEEN RESOLVED. THE ANEURYSM WAS SUCCESSFULLY EXCLUDED. NO OTHER ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12204911 ↗
• InjuryJul 14, 2021Partial Blockage; Partial Blockage

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

  Patient problems: Stenosis

  MAUDE report 12167083 ↗
• InjuryFeb 22, 2019Obstruction of Flow; Obstruction of Flow

  DURING THE REVIEW OF CUSTOMER PROVIDED CT, THE IMAGING REVIEWER IDENTIFIED THROMBUS IN THE TFFB-26-96-ZT (ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY). THE CT WAS PROVIDED FOR REVIEW TO ASSIST IN THE INVESTIGATION OF THE REPORT THAT THIS PATIENT HAD A LARGE AMOUNT OF THROMBUS BUILDING UP INSIDE THE ILIAC GRAFT LIMBS NEARLY 2 MONTHS AFTER EVAR IMPLANTATION. AS PREVIOUSLY REPORTED, THROMBECTOMY WAS PERFORMED ON BOTH ZSLE ILIAC LIMBS A FEW DAYS LATER TO RELIEVE PAIN IN THE PATIENT¿S LEGS. THE PHYSICIAN EXPLAINED THAT THE PATIENT¿S ANTIPHOSPHOLIPID ANTIBODY IS POSITIVE SO HE IS PROTHROMBOTIC AND ALSO CONFIRMED THAT THIS IS NOT A GRAFT ISSUE. PATIENT IS CURRENTLY STABLE. THE PREVIOUS REPORTS RELATED TO THIS PATIENT¿S THROMBUS ISSUE ARE MFR. REPORTS 1820334-2019-00322 AND 1820334-2019-00323.

  Patient problems: No Code Available; Thrombus

  MAUDE report 8362363 ↗
• InjuryFeb 21, 2019Activation Problem; Activation Problem

  IT WAS REPORTED THE STENT DID NOT OPEN. AS REPORTED, DURING THE PROCEDURE, THE VASCULAR SURGEON WANTED TO DEPLOY THE SUPRA RENAL STENT. IT WAS IMPOSSIBLE TO PUSH UP THE TOP CAP. HE HAD TO CONVERT TO OPEN SURGERY. ADDITIONAL PATIENT, DEVICE AND EVENT INFORMATION HAS BEEN REQUESTED. AT THE TIME OF THIS REPORT, THE SURGEON IS AWAY; HOWEVER, ADDITIONAL INFORMATION IS ANTICIPATED AFTER THE SURGEON RETURNS.

  Patient problems: No Code Available

  MAUDE report 8359601 ↗
• MalfunctionOct 29, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED WHEN THE TFFB-26-96-ZT WAS REMOVED FROM ITS INNER STERILE PACKAGING IT WAS NOTED THAT THERE WAS A HAIR OR FIBER OF ABOUT 5CM IN LENGTH PROTRUDING FROM THE PEEL-AWAY SHEATH. THE DOCTOR INSPECTED IT AND AGREED IT SHOULD NOT BE INSERTED INTO THIS PATIENT AND ANOTHER TFFB WAS OPENED AND USED. NO ADDITIONAL PROCEDURES WERE REQUIRED AS A RESULT OF THIS ISSUE AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8014093 ↗
• InjuryNov 17, 2017Positioning Failure; Device Operates Differently Than Expected; Positioning Failure; Device Operates Differently Than Expected

  THE USER FACILITY IN (B)(6) REPORTED THE (B)(6) FEMALE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). AS REPORTED, THE PATIENT¿S ANATOMY WAS SUITABLE FOR THE PROCEDURE. USING KILT TECHNIQUE, THE PROXIMAL EXTENSION WAS PLACED FIRST IN THE PATIENT BY RIGHT FEMORAL APPROACH WITHOUT PROBLEMS. THEN, THE MAIN BODY WAS ADVANCED TO THE TARGET SITE OVER A WIRE GUIDE BY RIGHT FEMORAL APPROACH. AFTER THE CONTRALATERAL LIMB WAS DEPLOYED, THE TRIGGER WIRE WAS REMOVED FROM THE SYSTEM WITHOUT RESISTANCE, AND THEN DEPLOYMENT OF THE TOP CAP WAS ATTEMPTED BY ADVANCING THE TOP CAP INNER CANNULA TO RELEASE THE SUPRARENAL STENT. HOWEVER, STRONG RESISTANCE WAS ENCOUNTERED AT THAT TIME AND THE INNER CANNULA COULD NOT BE PUSHED FORWARD AT ALL. IT JUST MADE THE STENT GRAFT DEFORM TEMPORARILY. THE CONDITION OF THE WIRE GUIDE WAS CHECKED UNDER FLUOROSCOPY. THE TIP WAS LOCATED PROPERLY IN THE DESCENDING AORTA. THE PHYSICIAN TRIED PULLING THE WIRE GUIDE AND IT MOVED FREELY WITHOUT PROBLEMS. THE PHYSICIAN DECIDED TO PLACE A CONTRALATERAL LEG. WHILE FIXING THE PROXIMAL PART OF THE MAIN BODY WITH A CODA BALLOON, THE PHYSICIAN TRIED DEPLOYING THE TOP CAP AGAIN

  Patient problems: No Code Available

  MAUDE report 7041614 ↗
• InjurySep 14, 2017Hole In Material; Leak/Splash; Hole In Material; Leak/Splash

  THE CLINICAL SPECIALIST REPORTED A (B)(6) PATIENT HAD A 5 CM ANEURYSM IN 2012. A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY WAS PLACED IN 2012. THIS PATIENT NOW HAS A 9 CM ANEURYSM IN 2017. AN ANGIOGRAM OF THE PREVIOUSLY PLACED GRAFT WAS TAKEN AND A TYPE II ENDOLEAK AND NO FLOW TO THE ANEURYSM SACK WAS FOUND. THEY SWITCHED TO A LAPAROTOMY TO OPEN UP THE ANEURYSM SACK, REMOVE THROMBUS AND LIGATE LUMBAR ARTERIES. IN DOING SO, THERE WAS A JET OF BLOOD COMING OUT OF A HOLE IN THE MAIN BODY. THEY ADDED GLUE ALL OVER THE GRAFT TO FIX THE HOLE. THEY CLOSED AND WILL HAVE A 30 DAY FOLLOW UP CT. ADDITIONAL INFORMATION HAS BEEN REQUESTED ABOUT THE PATIENT AND AVAILABILITY OF IMAGING FROM INITIAL IMPLANTATION, FOLLOW-UPS AND THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 6866017 ↗
• InjuryJun 16, 2017Defective Device; Defective Device

  IT WAS REPORTED THAT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) AND INFLAMMATORY BOWEL DISEASE (IBD) PROCEDURE WAS PLANNED FOR AN (B)(6) FEMALE PATIENT USING A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY. PRIOR TO THE PROCEDURE, THE PRODUCT WAS OPENED AND WHEN THE NURSE ATTEMPTED TO PREPARE THE DEVICE BY FLUSHING WITH SALINE HEPARIN SOLUTION, IT WAS NOTICED THAT THE STYLUS AND THE INNER CANNULA COULD NOT BE RETRACTED. THE STYLUS STUCK IN THE INNER CANNULA AND EVEN WITH THE HELP OF SURGICAL CLAMPS, COULD NOT BE REMOVED. THE PROCEDURE HAD TO BE STOPPED. THE PATIENT DID REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. THE PROCEDURE HAS TO BE COMPLETED IN A SECOND INTERVENTION AND REQUIRES A SECOND ANESTHESIA.

  Patient problems: No Code Available

  MAUDE report 6646391 ↗
• MalfunctionJun 1, 2017Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN THE PHYSICIAN OPENED THE PACKAGE OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY DURING THE PROCEDURE FOR ENDOVASCULAR EXCLUSION OF ABDOMINAL AORTIC ANEURYSM (AAA), THE FRONT OF THE MAIN SHEATH NEAR THE DILATOR WAS SLIGHTLY CONTORTED. WHEN THE MEDICAL TEAM INDUCTED THE MAIN SHEATH FROM THE RIGHT FEMORAL ARTERY VIA BILATERAL APPROACH, THE DEVICE BODY WAS NOTED TO BE SHORTENED DUE TO SHEATH CONTORTION AND WRINKLING. AFTER SEVERAL FAILED ATTEMPTS, THE PHYSICIAN SWITCHED TO THE LEFT FEMORAL APPROACH BUT THE DEVICE REMAINED SHORTENED. SINCE HE COULD NOT ENSURE THAT THE ILIAC LEGS COULD BE OPENED COMPLETELY, THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED TO SUCCESSFULLY FINISH THE PROCEDURE. THERE WAS NO REPORTED ADVERSE EVENT OR INJURY TO THE PATIENT. OF NOTE, CTA RESULTS PERFORMED PRE-PROCEDURE AND INTRAOPERATIVELY WERE NEGATIVE FOR OBVIOUS VESSEL TORTUOSITY BUT CONFIRMED THE PRESENCE OF CALCIFIED PLAQUE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6606139 ↗
• InjuryDec 23, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT RECEIVED A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY IMPLANT SOMETIME IN 2012. IN A RECENT FOLLOW UP, A CT SCAN FOUND AN ENDOLEAK TYPE 3 (GRAFT MATERIAL DEFECT) RIGHT AT THE BIFURCATION OF THE STENT GRAFT. THE ANEURYSM SAC HAS GROWN, FURTHER ACTION ON THIS IS PLANNED. THE PHYSICIAN WILL ATTEMPT A REPAIR WITH EITHER ANOTHER MANUFACTURERS DEVICE OR WITH AN EXTENSION FROM COOK. THE PATIENT IS CURRENTLY UNDER SURVEILLANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: Aneurysm; No Code Available

  MAUDE report 6202401 ↗
• MalfunctionAug 9, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED DURING AN ABDOMINAL ENDOVASCULAR ANEURYSM REPAIR PROCEDURE THAT PERSISTENT LEAKING AND CONTINUED BLOOD LOSS OCCURRED. PERSISTENT LEAKING OCCURRED FROM THE AREA WHERE THE TRIGGER WIRES SITS ON THE GREY INTRODUCER SYSTEM. EVEN ONCE ONE TRIGGER WAS REMOVED, THE BLOOD LOSS CONTINUED. WHEN BOTH TRIGGER WIRES WERE REMOVED, THE BLOOD LOSS STILL CONTINUED. IT WAS VERY SLOW BUT PERSISTENT. IN ADDITION, THE SCRUB NURSE BENT THE INTRODUCER INTO AN ¿S¿ SHAPE TO TRY AND BEND IT. THIS WAS DONE BEFORE ANYONE COULD STOP HER.

  Patient problems: Blood Loss

  MAUDE report 5856949 ↗
• InjuryJan 7, 2015Leak/Splash

  A (B)(6) YEAR OLD FEMALE PATIENT HAD A AAA AND RIGHT COMMON ILIAC ARTERY (CIA) ANEURYSM NOTED IN (B)(6) 2011. ON (B)(6) 2011, THE INFRARENAL AAA WAS 6.2CM WITH EXTENSION TO THE RIGHT RCIA AND RIIC. THE UNDERWENT INITIAL EVAR ON (B)(6) 2011. THE PHYSICIAN PLACED A ZENITH MAIN BODY AND TWO ZENITH ILIAC LEG GRAFTS. COMPLETION ANGIOGRAM INDICATED NO ENDOLEAK. A 6 MONTH FOLLOW UP CT INDICATED A TYPE II ENDOLEAK WITH NO INCREASE IN SIZE OF THE ANEURYSM. PHYSICIAN DECIDED TO FOLLOW UP WITH NO INTERVENTION. THE PATIENT WAS LOST TO FOLLOW UP FOR THREE YEARS. ON (B)(6) 2014 THE PATIENT CAME BACK FOR EVALUATION. THE ANEURYSM SAC HAD GROWN FROM 6.2CM TO 6.95CM WITH TYPE II ENDOLEAK. DUE TO THE DISTANCE THAT THE PATIENT LIVED IT WAS DECIDED THAT THE PATIENT WOULD UNDERGO OPEN SURGICAL REPAIR ON (B)(6) 2014. WHEN THE PATIENT WAS OPENED BY MIDLINE TRANSPERITONEAL INCISION IT WAS NOTED THAT THERE WAS WHITE OLD MURAL THROMBI EXPOSED AND WHILE REMOVING THAT FRESH RED THROMBI AND BLEEDING WERE FOUND NEAR THE ENDOGRAFT. AFTER REMOVING THE MURAL THROMBI THE PHYSICIAN FOUND MANY LOCALS PUMPING BLOOD FROM THE ENDOGRAFT. THE LEAK WAS FOUND NEAR THE SUTURE POINT ON THE GRAFT AND BACK BLEEDING FROM ONE LUMB

  Patient problems: Aneurysm; Surgical procedure, additional

  MAUDE report 4416961 ↗