Zenith Flex G48402Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10827002484020), received between Sep 20, 2016 and Mar 17, 2022 — classified as 8 injuries, 3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TYPE 3 ENDOLEAK OCCURRED ON A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY. THE GRAFT WAS DEPLOYED IN THE INFRARENAL AORTA OF AN (B)(6) FEMALE PATIENT DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. A TYPE 3 ENDOLEAK WAS IDENTIFIED ON THE FINAL ANGIOGRAM. A 32MM CODA BALLOON WAS INFLATED AT THE PROXIMAL SEAL ZONE, OVERLAP OF THE MAIN BODY AND ILIAC LEG BILATERALLY, AND AT THE DISTAL SEAL SITE OF THE ILIAC LEG. A MAIN BODY EXTENSION GRAFT WAS PLACED AT THE FIRST TWO COVERED STENTS OF THE MAIN BODY; HOWEVER, THE ENDOLEAK PERSISTED. THE AREA OF CONCERN WAS POSSIBLY BETWEEN THE SECOND AND THIRD STENT. TWO LIMBS FROM ANOTHER MANUFACTURER, 16 PROXIMALLY AND 14 DISTALLY, WERE PLACED TO BRING THE BIFURCATION HIGHER IN ORDER TO COVER THE POSSIBLE AREA OF CONCERN. THE LIMBS WERE REINFORCED AT THE PROXIMAL END OF THE ADDITIONAL LIMB GRAFTS WITH TWO BARE METAL STENTS FROM ANOTHER MANUFACTURER. THIS ASSISTED IN KEEPING THE LIMBS OPEN. THE PATIENTS NECK ANATOMY WAS DESCRIBED AS PARALLEL. IT WAS CONFIRMED THAT THERE WAS NO JUNCTIONAL SEPARATION THAT COULD HAVE LEAD TO THE ENDOLEAK. CALCIFICATION WAS NOTED AT THE PROXIMAL SEAL ZONE. NO OTHER ADVERSE EFFEC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13802430 ↗
• InjuryMar 17, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TYPE 1A ENDOLEAK OCCURRED ON ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY GRAFT DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE ON A MALE PATIENT. THE DEVICE WAS DEPLOYED PER THE INSTRUCTIONS FOR USE (IFU) AND THE REST OF THE PROCEDURE WENT WELL. A FINAL ANGIOGRAM REVEALED A TYPE 1A ENDOLEAK. IN RESPONSE, THE PROXIMAL SEAL ZONE WAS RE-BALLOONED WITH A CODA BALLOON. FOLLOWING, AN ADDITIONAL ANGIOGRAM REVEALED A SLOWER, BUT STILL EXISTING ENDOLEAK. THEREFORE, THE PHYSICIAN PLACED AN ADDITIONAL STENT FROM ANOTHER MANUFACTURER IN THE PROXIMAL SEAL ZONE OF THE ENDOGRAFT. THE STENT WAS THEN BALLOONED WITH A CODA BALLOON AT A PRESSURE OF LESS THAN 5ATM. ANOTHER ANGIOGRAM WAS PERFORMED AND REVEALED A LESSER, BUT STILL EVIDENT ENDOLEAK. IT WAS THEN CONSIDERED THAT THE LEAK COULD BE ATTRIBUTED TO A TYPE 2 ENDOLEAK. THE OPERATOR DECIDED TO END THE PROCEDURE SUCCESSFULLY AND FOLLOW UP WITH THE PATIENT IN THE FUTURE TO PERFORM MORE IMAGING TO ASSESS ENDOLEAK STATUS. THE PATIENT DID NOT EXPERIENCE COMPLICATIONS. NO FOLLOW UP IMAGING WAS PERFORMED PRIOR TO THE PATIENT'S DISMISSAL FROM THE HOSPITAL. THERE WERE NO ALTERATIONS MADE TO THE GRAFT PRIOR TO IMPL

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13802201 ↗
• InjuryDec 13, 2019Complete Blockage; Complete Blockage

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

  Patient problems: Death; Ischemia; No Code Available

  MAUDE report 9466645 ↗
• MalfunctionNov 27, 2019Difficult or Delayed Activation; Difficult or Delayed Activation

  DURING THE PRELIMINARY INVESTIGATION OF THE DEVICE CONDUCTED ON 16JUN2020, IT WAS DETERMINED THAT THE UNKNOWN OBJECT IN THE LUMEN OF THE CATHETER WAS MOST LIKELY ADHESIVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9387069 ↗
• InjuryJun 12, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. THIS EVENT IS RELATED TO THE REPORT WITH MFR NUMBER: 1820334-2019-02700.

  Patient problems: No Code Available

  MAUDE report 8692782 ↗
• InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 AN INTERNAL DEVICE TRACKING REPORT WAS RECEIVED WHICH CONTAINED INFORMATION THAT A PATIENT DEATH HAD OCCURRED. A LIST OF DEVICES IMPLANTED ON (B)(6) 2019, WAS PROVIDED IN THE REPORT. DEVICES LISTED ON THE REPORT: TFFB-22-82-ZT, LOT# 9171116; ZSLE-11-90-ZT, LOT# 7589621; ZSLE-11-74-ZT, LOT# 9172498; ESBE-24-58-ZT, LOT# 7530242. IN RESPONSE TO A FOLLOW UP. REQUEST FOR ADDITIONAL INFORMATION, THE PHYSICIAN STATED THAT HER DEATH WAS NOT DIRECTLY RELATED TO THE DEVICE. DURING THE INITIAL SURGERY, THEY DID OVER-BALLOON THE DEVICE, WHICH CAUSED A SMALL TEAR IN THE AORTA, BUT WERE ABLE REPAIR THAT IMMEDIATELY. THE PATIENT WAS BROUGHT BACK FOR A SECONDARY SURGERY TO REPAIR BLEEDING IN THE GROIN, WHICH RESULTED FROM THE CLOSURE DEVICE USED, AND NOT RELATED TO THE COOK ENDOGRAFTS. DURING THIS SURGERY, THE PATIENT SUFFERED MULTIPLE CARDIAC EVENTS, WHICH THE DOCTOR BELIEVES WAS THE CAUSE OF THE ISCHEMIC BOWEL EVENT THAT LEAD TO THE PATIENT'S DEATH.

  Patient problems: Death; No Code Available

  MAUDE report 8484358 ↗
• InjuryDec 21, 2017Leak/Splash; Material Separation; Leak/Splash; Material Separation

  ADDITIONAL INFORMATION WAS PROVIDED STATING, "THE PHYSICIAN PUTS TOP OF CODA BALLOON ABOUT 1 CM PAST THE GATE BEFORE INFLATING DESPITE BEING TOLD NOT TO DO THIS. ALSO, WHEN IPSILATERAL SIDE WAS BALLOONED, THE STENT WAS VERY OBVIOUSLY JETTING OUT. " IT WAS ALSO REPORTED THAT THE PATIENT HAD, "MODERATELY TORTUOUS ANATOMY," AND, "ON PRIOR CT IMAGING THERE WAS CALCIFICATION NEAR THE SITE WITH A MURAL THROMBUS COVERING IT."

  Patient problems: No Code Available

  MAUDE report 7140074 ↗
• InjuryMay 3, 2017Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE FOR ABDOMINAL AORTIC ANEURYSM (AAA) A MAIN BODY AND TWO ILIAC LEG GRAFTS WERE PLACED, AND A 32 MILLIMETER (MM) CODA BALLOON WAS USED FOR TOUCH-UP OF THE STENT GRAFT. INTRA-PROCEDURAL ANGIOGRAM RESULTS CONFIRMED TYPE IIIB AND IV ENDOLEAKS OF THE MAIN BODY. THE PHYSICIAN DECIDED THAT SINCE THE AAA HAD NOT RUPTURED A "WAIT-AND-SEE APPROACH" WOULD BE TAKEN, AND THE PROCEDURE WAS COMPLETED. COMPUTERIZED TOMOGRAPHY SCAN RESULTS PERFORMED ON (B)(6) 2017 CONFIRMED A MINOR LEAK NEAR THE CONTRALATERAL MAIN BODY LIMB. THE MEDICAL STAFF SUSPECTED IT TO BE EITHER A TYPE III OR TYPE II LEAK BASED ON IMAGING RESULTS. THE MEDICAL TEAM ULTIMATELY DECIDED THAT SINCE THE AAA WAS SMALL ORIGINALLY, THEY WOULD CONTINUE TO MONITOR THE LEAK WITHOUT ADDITIONAL INTERVENTION. OF NOTE, THE PHYSICIAN ALSO REPORTED THAT THE PATIENT'S PROXIMAL AORTIC NECK WAS "LONG ENOUGH" SO THE POSSIBILITY OF OCCURRENCE OF ENDOLEAK WAS EXTREMELY LOW. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6541848 ↗
• MalfunctionApr 11, 2017Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE WITH A ZENITH FLEX ABDOMINAL AORTIC ANEURYSM (AAA) ENDOVASCULAR GRAFT BIFURCATED MAIN BODY, WHILE FLUSHING THE DEVICE WITH SALINE, IT WAS NOTICED THAT THE TIP OF THE SHEATH WAS FRAYED. ANOTHER MANUFACTURER'S DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. ADDITIONALLY, IT WAS REPORTED THAT THIS WAS NOTICED PRIOR TO PATIENT CONTACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6481041 ↗
• InjuryNov 29, 2016Leak/Splash; Leak/Splash

  ON (B)(6) 2016, AN (B)(6) YEAR-OLD MALE PATIENT UNDERWENT ENDOVASCULAR ANEURYSM REPAIR (EVAR) WITH ZENITH MAINBODY AND TWO ILIAC LEG GRAFTS BY RIGHT APPROACH. THE PATIENT WAS SUITABLE FOR THE ENDOVASCULAR REPAIR AND THE PROCEDURE WAS CONDUCTED AS LABELED. DEPLOYMENT OF EACH STENT GRAFT WAS SUCCESSFULLY COMPLETED. HOWEVER, FINAL CONFIRMATORY ANGIOGRAPHY PERFORMED ABOVE THE RENAL ARTERIES AFTER TOUCH-UP BALLOONING CONFIRMED AN ENDOLEAK NEAR THE FLOW-DIVIDER OF THE MAINBODY. THEN, ANGIOGRAPHY WAS CONDUCTED AGAIN IN THE MAINBODY AND AN ENDOLEAK FROM THE SAME SITE WAS CONFIRMED. THE PHYSICIAN JUDGED THAT IT WAS NOT TYPE IA OR TYPE III BUT TYPE IV ENDOLEAK FIRST. HOWEVER, HE COULD NOT DENY A POSSIBILITY THAT THE ENDOLEAK WAS TYPE IIIB (PIN HOLE) JUDGING FROM HOW THE FLOW LEAKED. HEPARIN NEUTRALIZATION WAS CONDUCTED AND THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-SEE APPROACH. (ADDITIONAL STENT GRAFT PLACEMENT WITH GORE'S EXCLUDER LEG INSIDE ZENITH WILL BE CONSIDERED IF THE ENDOLEAK DOES NOT DISAPPEAR DURING FOLLOW-UP.) THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

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

  MAUDE report 6132493 ↗
• MalfunctionSep 20, 2016Leak/Splash; Leak/Splash

  ON (B)(6) 2016, A (B)(6)-YEAR-OLD MALE PATIENT UNDERWENT EVAR FOR AAA. THE PATIENT WAS SUITABLE FOR THE PROCEDURE. AFTER STENT GRAFT PLACEMENT WAS CONDUCTED AS PLANNED, THE CONFIRMATORY ANGIOGRAPHY CONFIRMED MASSIVE TYPE IV ENDOLEAK. HOWEVER, THE PROCEDURE WAS FINISHED WITHOUT ADDITIONAL TREATMENT, AND THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-SEE APPROACH. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5962804 ↗