Zenith G32537Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10827002325378), received between Dec 7, 2016 and Mar 25, 2024 — classified as 1 death, 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 reports).

111 other recalls cover devices cleared under the same FDA submission (P020018); they may or may not involve this specific model.

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.

• InjuryMar 25, 2024Material Twisted/Bent; Material Twisted/Bent

  ACCORDING TO THE INITIAL REPORTER: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A ZFEN PROCEDURE ON (B)(6) 2024 IN WHICH THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY, G32537, WAS IMPLANTED. THE PROXIMAL BODY ZFEN GRAFT WAS TWISTED WITHIN THE SHEATH. THE RRA WAS A 10MM SCALLOP THAT WAS SUPPOSED TO BE AT 9:30 AND UNDER FLUORO/INSIDE THE SHEATH THE SCALLOP WAS AT ABOUT 1:00. THE LRA WAS IN WHAT LOOKED TO BE THE CORRECT LOCATION (29MM FROM PE) AS WELL AS THE ANTERIOR POSTERIOR MARKS. ONCE WE STARTED TO UNSHEATHE THE RRA FEN STARTED TO MOVE TOWARDS THE PATIENTS RIGHT SOME, WE HAD TO DO SOME WIGGLING OF THE GRAFT TO GET IT CLOSER TO THE CORRECT POSITION. ONCE THE GRAFT WAS FULLY DEPLOYED THE FEN WAS CLOSER TO 10:15 TO 10:30 AS OPPOSED TO 9:30 MAKING CANNULATION OF THE RENAL VERY DIFFICULT. I DO NOT HAVE PICTURES. ADDITIONAL INFORMATION RECEIVED: THE PHYSICIAN THINK THE DEVICE BEING INCORRECTLY LOADED IN THE SHEATH CAUSED THE ISSUE THE DEVICE WAS INSPECTED PRIOR TO USE IN ORDER TO ENSURE NO DAMAGE HAS OCCURRED; NO DAMAGE HAD OCCURRED TO PACKAGING TO DEVICE THE DEVICE WAS POSITIONED ON THE PATIENT¿S ABDOMEN PRIOR TO INSERTION TO CONFIRM THAT THE GRAFT WAS IN THE CORRECT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18971225 ↗
• MalfunctionMar 25, 2024Difficult or Delayed Positioning; Material Twisted/Bent; Difficult or Delayed Positioning; Material Twisted/Bent

  A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A ZFEN PROCEDURE ON (B)(6) 2024 IN WHICH THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY, G32537, WAS IMPLANTED. "THE PROXIMAL BODY ZFEN GRAFT WAS TWISTED WITHIN THE SHEATH. THE RRA (RIGHT RENAL ARTERY) WAS A 10MM SCALLOP THAT WAS SUPPOSED TO BE AT 9:30 AND UNDER FLUORO/INSIDE THE SHEATH THE SCALLOP WAS AT ABOUT 1:00. THE LRA WAS IN WHAT LOOKED TO BE THE CORRECT LOCATION (29MM FROM PE) AS WELL AS THE ANTERIOR POSTERIOR MARKS. ONCE WE STARTED TO UNSHEATHE THE RRA FEN STARTED TO MOVE TOWARDS THE PATIENTS RIGHT SOME, WE HAD TO DO SOME WIGGLING OF THE GRAFT TO GET IT CLOSER TO THE CORRECT POSITION. ONCE THE GRAFT WAS FULLY DEPLOYED THE FEN WAS CLOSER TO 10:15 TO 10:30 AS OPPOSED TO 9:30 MAKING CANNULATION OF THE RENAL VERY DIFFICULT. I DO NOT HAVE PICTURES." ADDITIONAL INFORMATION RECEIVED: THE PHYSICIAN THINK THE DEVICE BEING INCORRECTLY LOADED IN THE SHEATH CAUSED THE ISSUE THE DEVICE WAS INSPECTED PRIOR TO USE IN ORDER TO ENSURE NO DAMAGE HAS OCCURRED; NO DAMAGE HAD OCCURRED TO PACKAGING TO DEVICE THE DEVICE WAS POSITIONED ON THE PATIENT¿S ABDOMEN PRIOR TO INSERTION TO CONFIRM THAT THE GRAFT WAS IN THE CORRECT ORIENTATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966645 ↗
• MalfunctionJun 14, 2023Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  UPON DEPLOYMENT AND ATTEMPTED REMOVAL OF THE BLACK TRIGGER WIRE, THE TRIGGER WIRE WOULD NOT RELEASE FROM THE TOP CAP AND THE GRAFT WAS BEING PULLED DOWN AND CRUNCHED IN AN ACCORDION-LIKE MANNER. REPEATED ATTEMPT TO DEPLOY WERE UNSUCCESSFUL. MANUAL DEPLOYMENT WAS COMPLETED (WITH WHITE TRIGGER WIRE) WITH USE OF KELLY CLAMPS TO RELEASE THE BOTTOM OF GRAFT FOLLOWED BY MANUAL DEPLOYMENT OF THE BLACK TRIGGER WIRE AND DEPLOYMENT OF THE SUPRARENAL TOP CAP. THE GRAFT WAS ABLE TO BE REFORMED BUT NOT ENTIRELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17132116 ↗
• MalfunctionApr 13, 2023Failure to Advance; Difficult or Delayed Activation; Failure to Advance; Difficult or Delayed Activation

  THE PROXIMAL PIECE WOULD NOT ADVANCE AS IT WAS BEING ADVANCED OVER THE STIFF WIRE. THEREFORE, AN EVAR WAS PERFORMED TO SUCCESSFULLY COMPLETE THE PROCEDURE. WHEN THE PROXIMAL PIECE WAS BEING PREPPED AND FLUSHED, THE TECHNICIAN BENT THE SHEATH AND IN TURN IT IS BELIEVED (BY BOTH THE SALES REPRESENTATIVE AND THE PHYSICIAN) THAT THE TECHNICIAN BENT THE INNER CANNULA. THE BEND WAS WHERE THE GRAFT MATERIAL STARTS. AT THAT CERTAIN AREA, THEY BELIEVE THAT THE INNER CANNULA IS COMPRESSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16739374 ↗
• MalfunctionFeb 27, 2023Malposition of Device; Physical Resistance/Sticking; Physical Resistance/Sticking

  A 79 YEAR OLD MALE PATIENT UNDERWENT A ZENITH FENESTRATED GRAFT IMPLANT PROCEDURE IN WHICH THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY GRAFT WAS USED. DURING DEPLOYMENT, THE BLACK TRIGGER WIRE STAYED FIXATED TO THE CAP AND WHEN THE TRIGGER WIRE WAS PULLED IT PULLED DOWN ON THE GRAFT AND DELIVERY SYSTEM. THIS CAUSED THE GRAFT TO COME DOWN LOWER IN THE PATIENT. THE GRAFT WAS EVENTUALLY DEPLOYED BY THE PHYSICIAN PULLING DOWN ON THE TRIGGER WIRE AND WITH A LOT OF MANIPULATION AND RELEASE, PULLING DOWN AND RELEASE TO ALLOW THE GRAFT TO RELAX EACH TIME. THE GRAFT HAD MOVED SIGNIFICANTLY, HOWEVER THE PHYSICIAN USED THE THIRD TRIGGER WIRE TO ASSIST IN GETTING THE GRAFT PUSHED BACK UP INTO PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16449235 ↗
• InjuryDec 21, 2022Material Twisted/Bent; Activation, Positioning or Separation Problem; Material Twisted/Bent

  A FENESTRATED [EVAR] ENDOVASCULAR REPAIR WAS PERFORMED ON AN 82-YEAR-OLD FEMALE PATIENT WITH A ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY. THE RIGHT RENAL FENESTRATION DID NOT OPEN, EVEN AFTER BALLOONING (USED A COOK MEDICAL CODA BALLOON) WHILE ATTEMPTING TO CANNULATE. MAYBE THE TWO MIDDLE GOLD MARKERS HAD STUCK TOGETHER. AFTER SOME MANIPULATION THE STENT EVENTUALLY DEPLOYED, HOWEVER, LOST FUNCTION TO RIGHT RENAL AS THE GRAFT COVERED THE RENAL BRANCH. THE PHYSICIAN ALSO STATED COULD NOT GET AN .014 WIRE THROUGH THE RIGHT RENAL BRANCH OF THE GRAFT. ADDITIONAL DEVICES IMPLANTED DURING PROCEDURE: ENDOLOGIC MAIN BODY AFX, GORE VBX 6X29 STENT IN THE SMA, ATRIUM MEDICAL ICAST 6X22 STENT IN THE LEFT RENAL ARTERY.

  Patient problems: Obstruction/Occlusion; Renal Failure

  MAUDE report 16029221 ↗
• InjuryDec 21, 2022Difficult to Open or Close; Difficult to Open or Close

  A FENESTRATED [EVAR] ENDOVASCULAR REPAIR WAS PERFORMED ON AN 82-YEAR-OLD FEMALE PATIENT WITH A ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY. THE RIGHT RENAL FENESTRATION DID NOT OPEN, EVEN AFTER BALLOONING (USED A COOK MEDICAL CODA BALLOON) WHILE ATTEMPTING TO CANNULATE. MAY BE THE TWO MIDDLE GOLD MARKERS HAD STUCK TOGETHER. AFTER SOME MANIPULATION THE STENT EVENTUALLY DEPLOYED, HOWEVER, LOST FUNCTION TO RIGHT RENAL AS THE GRAFT COVERED THE RENAL BRANCH. THE PHYSICIAN ALSO STATED COULD NOT GET AN .014 WIRE THROUGH THE RIGHT RENAL BRANCH OF THE GRAFT. ADDITIONAL DEVICES IMPLANTED DURING PROCEDURE: ENDOLOGIC MAIN BODY AFX GORE VBX 6X29 STENT IN THE SMA ATRIUM MEDICAL ICAST 6X22 STENT IN THE LEFT RENAL ARTERY

  Patient problems: Obstruction/Occlusion

  MAUDE report 16025917 ↗
• InjurySep 20, 2021Inadequacy of Device Shape and/or Size; Improper or Incorrect Procedure or Method; Inadequacy of Device Shape and/or Size

  A MALE PATIENT OF UNDISCLOSED AGE UNDERWENT A FENESTRATED AORTIC ANEURYSM REPAIR IN WHICH THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY (G32537) AND THE DISTAL BIFURCATED BODY (G32577) WAS USED. THERE HAD BEEN TWO FENESTRATED PROCEDURES SCHEDULED FOR THE SAME DAY. IT WAS NOTED AFTER THE FIRST PROCEDURE THAT THE INCORRECT GRAFTS HAD BEEN PLACED IN THE WRONG PATIENT. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL AND THE GRAFTS WERE WORKING AS THEY WERE CLOSE TO THE SIZE NEEDED AND ORDERED FOR THIS PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12503029 ↗
• DeathApr 16, 2019Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS DISCOVERED DURING A LITERATURE SEARCH WHERE THE ARTICLE DESCRIBED THE EVENT (BUT DID NOT LIST A MANUFACTURER OR DEVICE INFORMATION) AS: THE PATIENT DEVELOPED ACUTE PARALYSIS 3.5 HOURS POST PROCEDURE. MULTIPLE THROMBI WERE IDENTIFIED IN THE TERRITORY OF THE GRAFT (THE AORTA, LEFT RENAL, BILATERAL COMMON EXTERNAL ILIAC ARTERIES AND BILATERAL SUPERFICIAL FEMORAL AND PROFUNDA FEMORAL ARTERIES) AT THE TIME OF EXPLORATORY LAPAROTOMY. THIS WAS TREATED WITH THROMBECTOMIES, PATCH ANGIOPLASTIES AND ANGIOJET OF THE GRAFT. HISTOLOGIC PROCESSING OF THE EXTRACTED AORTIC THROMBI SHOWED IDENTICAL POLYMERS TO THOSE SEEN IN THE GASTROINTESTINAL RESECTION SPECIMEN. ONE DAY AFTER THE AORTIC REPAIR THE PATIENT DEVELOPED MELENA, ULTIMATELY REQUIRING PROCTECTOMY DUE TO THE INTRAOPERATIVE IMPRESSION OF ISCHEMIA. THREE DAYS AFTER THE AORTIC REPAIR THE PATIENT DIED OF CARDIAC ARRHYTHMIA IN THE SETTING OF RENAL AND RESPIRATORY FAILURE. A SPECIFIC DATE OF DEATH HAS NOT BEEN SUPPLIED. (AN EARLIER DESCRIPTION OF THE EVENT DESCRIBED THE TIME BETWEEN THE EVENT AND THE PATIENT DEATH AS LONGER IN DURATION.) ON 5TH APRIL 2019 THE MANUFACTURER RECEIVED A RESPONSE TO THEIR ENQUIRIES WHICH

  Patient problems: Death; Paralysis; Unspecified Infection

  MAUDE report 8520994 ↗
• InjuryJan 28, 2019Insufficient Flow or Under Infusion; Therapeutic or Diagnostic Output Failure

  THE ORIGINAL PROCEDURE WAS PERFORMED IN (B)(6) 2018. DURING (B)(6) 2018 COMPUTED TOMOGRAPHY ANGIOGRAPHY, IT WAS OBSERVED THAT LITTLE TO NO CONTRAST WAS TRAVELING TO THE LEFT RENAL ARTERY. THE GORE VBX BALLOON EXPANDABLE STENT THAT WAS IMPLANTED ALONG WITH THE COOK FENESTRATED GRAFT AND IS SUPPOSED TO KEEP COOK'S STENT ALIGNED WITH THE RENAL ARTERY. THE RENAL APPEARS TO HAVE POSSIBLY SHUT DOWN. THE PHYSICIAN PLANS DUPLEX ULTRASOUND OF RENAL TO DETERMINE BLOODFLOW TO LEFT KIDNEY.

  Patient problems: No Code Available; Renal Failure

  MAUDE report 8283209 ↗
• MalfunctionDec 11, 2017Inadequate Instructions for Healthcare Professional

  THE GRAFT WAS ORDERED AND CORRECTLY BUILT WITH A SCALLOP AT 11:15. THE FORM INDICATES THE SCALLOP IS AT 1:15. THE IMPLANTING TEAM WAS SURE IT WAS JUST A TYPO HOWEVER IT CAUSED SERIOUS CONCERN AND DISTRACTION PRECEDING IMPLANTATION OF THE DEVICE. THE IMPLANTING TEAM COULD TELL BY THE PHOTOS THAT THE DEVICE HAD BEEN BUILT CORRECTLY, AND THE SURGEON WAS HIGHLY EXPERIENCED WITH ZENITH FEN/BRANCH DEVICES.

  Patient problems: No Information

  MAUDE report 7106634 ↗
• InjurySep 25, 2017Insufficient Device Problem Information

  ON (B)(6) 2011 THE PATIENT RECEIVED THE DEVICE ALONG WITH 3 ADDITIONAL GRAFTS: THERE WERE NO DIFFICULTIES DEPLOYING THE DEVICE. A MOLDING BALLOON WAS USED. THE LEFT RENAL STENT WAS FLARED. ILIAC ARTERY ANGIOPLASTY WAS PERFORMED AFTER DEVICE DEPLOYMENT. NO PATIENT-RELATED ADVERSE EVENTS WERE OBSERVED DURING THE PROCEDURE. PER SITE, THE ENDOGRAFTS AND THE RENAL STENT WERE PATENT, WITH NO KINK OR ENDOLEAK ON THE COMPLETION ANGIOGRAM. THE CORE LAB CONCURRED WITH THE SITE¿S ASSESSMENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011 (THREE DAYS POST-PROCEDURE). PER (B)(6) ANALYSIS, ALL FOLLOW-UP IMAGING THROUGH 3 YEARS POST-IMPLANT INDICATED NO ISSUES, EXCEPT A SMALL TYPE II ENDOLEAK AT 2 YEARS THAT WAS RESOLVED AT 3 YEARS. THE 4-YEAR FOLLOW-UP CT SCAN WAS NOT DONE. THE ANEURYSM DIAMETER DECREASED FROM 6.14 CM AT TWO DAYS POST-IMPLANT TO 4.82 CM AT 5 YEARS. ON (B)(6) 2016 CT SCAN (5-YEAR FOLLOW-UP, 1887 DAYS POST-PROCEDURE): PER (B)(6): ENDOVASCULAR GRAFT AND FENESTRATED AND STENTED LEFT ACCESSORY RENAL ARTERY PATENT AND INTACT WITH NO EVIDENCE OF A KINK OR AN ENDOLEAK. ANGULATION OF THE LEFT ACCESSORY RENAL ARTERY STENT WAS NOTED AT THE OSTIUM, WITH SEVERE FOCAL STENOSIS. T

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Stenosis

  MAUDE report 6892532 ↗
• MalfunctionDec 7, 2016Device Operates Differently Than Expected

  DURING A FENESTRATED ABDOMINAL AORTIC ANEURYSM PROCEDURE, WHILE STILL SHEATHED, THE MARKERS FOR ANTERIOR/POSTERIOR APPEARED TO BE OFF TO ONE SIDE WHICH CAUSED SOME CONFUSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6153387 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020018. One submission often covers many models, so check the product and lot details in each record.

• Z-3157-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-30-39, REF G32183, 20 Fr. ID/ 7.7 OD, Sterile.
• Z-3134-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-28-96-ZT, REF G48418, 20 Fr ID/ 7.7 mm OD, Sterile
• Z-3139-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-10-71-ZT, REF G48444, 14 Fr ID/ 5.3 mm OD, Sterile.
• Z-3156-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-22-29, REF G32179, 18 Fr. ID/ 6.90 OD, Sterile.
• Z-3137-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-32-96-ZT, REF G48428, 20 Fr ID/ 7.7 mm OD, Sterile.
• Z-3152-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-73-ZT, REF G48476, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3144-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-90-ZT, REF G48463, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3132-2011 · Apr 15, 2011 · Terminated
  Cook Medical, Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-26-96-ZT, REF G48413, 18 Fr ID/ 7.1 mm OD, Sterile.
• Z-3141-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-14-56-ZT, REF G48455, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3138-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-36-95-ZT, REF G48432, 22 Fr ID/ 8.5 mm OD, Sterile.
• Z-3130-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-24-82-ZT, REF G48407, 18 Fr ID/ 7.1 mm OD, Sterile
• Z-3140-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-12-56-ZT, REF G48449, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3153-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48477, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3148-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-73-ZT, REF G48470, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3143-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-73-ZT, REF G48462, 16Fr ID/ 6.0 mm OD, Sterile.

…and 96 more.