Zenith G32538Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10827002325385), received between Jan 14, 2018 and Jun 23, 2024 — classified as 4 deaths, 5 injuries, 4 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.

• MalfunctionJun 23, 2024Material Twisted/Bent; Material Twisted/Bent

  A PATIENT UNDERWENT A FENESTRATED ENDOVASCULAR REPAIR PROCEDURE IN WHICH THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY WAS FOUND TO BE TWISTED INSIDE THE SHEATH. THE PHYSICIAN DEPLOYED THE GRAFT SLOWLY AND TURNED SO THE GRAFT DEPLOYED AND LANDED CORRECTLY AND STRAIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19591841 ↗
• MalfunctionJun 23, 2024Material Twisted/Bent; Material Twisted/Bent

  DURING PROCEDURE, THE ANTERIOR AND POSTERIOR ALIGNMENT MARKS WERE OFF/INCORRECT. THEY WERE ROTATED AT LEAST 45 MINUTES AND DID NOT LINE UP IN ANTERIOR/POSTERIOR PROJECTION. THEY DID NOT REFERENCE THE ALIGNMENT MARKS AFTER NOTICING THEY WERE INCORRECT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REFERENCING TO THE OTHER GRAFT MARKERS. THERE WERE NO ADVERSE OUTCOMES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19591821 ↗
• MalfunctionDec 20, 2023Physical Resistance/Sticking; Difficult or Delayed Separation; Physical Resistance/Sticking; Difficult or Delayed Separation

  DURING A ZFEN CASE THE BLACK TRIGGER WIRE WAS EXTREMELY DIFFICULT TO REMOVE. IT WAS BOWING THE DELIVERY SYSTEM. IT TOOK THE SURGEON SEVERAL ATTEMPTS TO DO REMOVE IT. ILIACS WERE NOT TORTUOUS. PRESERVATION OF THE VISCERALS (RENALS & SMA) AND INTEGRITY OF DEVICE NOT IMPACTED. PATIENT¿S AAA WAS PROPERLY TREATED WITH PROPER SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361671 ↗
• InjuryJul 17, 2023Defective Device; Defective Device

  THE ZFEN DEVICE APPEARED DIFFICULT TO READ UNDER FLOURO WHILE PERFORMING A/P CONFIRMATION. ANTERIOR MARKERS REMAINED AT/NEAR 12 O¿CLOCK POSITION ORIENTATION THROUGHOUT A 360-DEGREE ROTATION, AS WELL AS SMALL FEN MARKERS APPEARED DIFFICULT TO CONFIRM ORIENTATION. UPON UNSHEATHING, THE GRAFT APPEARED SEVERELY TWISTED, CAUSING MISS-ALIGNMENT AND INEVITABLE EXPLANT.

  Patient problems: Insufficient Information

  MAUDE report 17339742 ↗
• DeathJun 29, 2023Defective Device; Material Twisted/Bent; Defective Device; Material Twisted/Bent

  AFTER INITIAL INSPECTION ON OPENING, THE ZFEN DEVICE APPEARED DIFFICULT TO READ UNDER FLOURO WHILE PERFORMING A/P CONFIRMATION. ANTERIOR MARKERS REMAINED AT/NEAR 12 O¿CLOCK POSITION ORIENTATION THROUGHOUT A 360-DEGREE ROTATION, AS WELL AS SMALL FEN MARKERS APPEARED DIFFICULT TO CONFIRM ORIENTATION. ONCE THE GRAFT WAS COMPLETELY UNSHEATHED THE USER COULD SEE THAT THE GRAFT WAS TWISTED FROM PROXIMAL EDGE TO DISTAL END. THEY MADE NUMEROUS ATTEMPTS TO ROTATE THE DEVICE IN ORDER TO CORRECTLY ALIGN, HOWEVER THE FEN MARKERS WERE INDISTINGUISHABLE. UPON UNSHEATHING, THE GRAFT APPEARED SEVERELY TWISTED, THE GRAFT WAS ULTIMATELY BALLOONED IN AN ATTEMPT TO UNTWIST. UNABLE TO ROTATE AND ALIGN CORRECTLY BECAUSE THEY COULD NOT IDENTIFY THE FEN MARKERS; CAUSING MISS-ALIGNMENT AND INEVITABLE EXPLANT. THE PATIENT DID NOT SURVIVE THE ATTEMPT TO EXPLANT THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 17222917 ↗
• DeathDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THROMBOSIS OF THE DEVICE. (BELIEVED TO BE MOST LIKELY DUE TO HYPOVOLEMIA.). PATIENT DEATH, POSSIBLE MYOCARDIAC ARREST. THE PHYSICIAN BELIEVES PATIENT DEATH WAS NOT CAUSED BY THE IMPLANTED DEVICE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15926145 ↗
• DeathDec 4, 2022Obstruction of Flow

  THROMBOSIS OF THE DEVICE. (BELIEVED TO BE MOST LIKELY DUE TO HYPOVOLEMIA.) PATIENT DEATH, POSSIBLE MI OR CARDIAC ARREST. THE PHYSICIAN BELIEVES PATIENT DEATH WAS NOT CAUSED BY THE IMPLANTED DEVICE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15912597 ↗
• InjuryOct 14, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT APPEARS THAT THE LARGE FENESTRATION BUILT FOR 12:00 POSITION IS CLOSER TO 12:15 OR 12:30 IN RELATION TO THE 12:00 VERTICAL ANTERIOR MARKER. THE DISCREPANCY WAS ENOUGH THAT THE DOCTOR DECIDED TO GO BACK IN AND CANNULATE/STENT THE SUPERIOR MESENTERIC ARTERY (SMA) TO CORRECT THE MISS-ALIGNMENT. IN THE ATTACHED AP IMAGE, IT¿S APPEARS THAT THE SMA OSTIUM OUTLINE IS OFF TO THE RIGHT OF THE LARGE FENESTRATION.

  Patient problems: No Code Available

  MAUDE report 10680224 ↗
• InjuryOct 6, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size; Malposition of Device

  IT APPEARS THAT THE LARGE FENESTRATION BUILT FOR 12:00 POSITION IS CLOSER TO 12:15 OR 12:30 IN RELATION TO THE 12:00 VERTICAL ANTERIOR MARKER. THE DISCREPANCY WAS ENOUGH THAT THE DOCTOR DECIDED TO GO BACK IN AND CANNULATE/STENT THE SUPERIOR MESENTERIC ARTERY (SMA) TO CORRECT THE MISS-ALIGNMENT. IN THE AP IMAGE, IT APPEARS THAT THE SMA OSTIUM OUTLINE IS OFF TO THE RIGHT OF THE LARGE FENESTRATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Consequences Or Impact To Patient

  MAUDE report 10637041 ↗
• InjuryNov 3, 2019Material Split, Cut or Torn

  A TYPE III ENDOLEAK WAS NOTED BETWEEN THE PROXIMAL AND DISTAL COMPONENTS. THE DEVICES WERE RE-BALLOONED AT THE OVERLAP AND THE FABRIC WAS TORN DUE TO BALLOONING. AN ADDITIONAL GRAFT (ESBE-32-39-ZT) WAS PLACED TO REPAIR THE TEAR. THE LEAK PERSISTED, BUT APPEARED TO PARTIALLY RESOLVE. THE PATIENT WAS DISCHARGED, AND WILL RETURN IN 30 DAYS FOR A SCAN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9270651 ↗
• DeathApr 8, 2019Adverse Event Without Identified Device or Use Problem

  THE DEVICE WAS PLACED SUCCESSFULLY WITH NO ISSUES NOTED DURING THE PROCEDURE. UPON FINAL ANGIOGRAM IT WAS NOTICED THAT THE SUPERIOR MESENTERIC ARTERY (SMA) AND THE CELIAC ARTERY WERE OCCLUDED. AN ATTEMPT WAS MADE TO PLACE A WIRE IN THE SUPERIOR MESENTERIC ARTERY (SMA) AND CELIAC ARTERIES BUT WAS NOT SUCCESSFUL. THE PATIENT UNDERWENT A CT SCANNED AGAIN IMMEDIATELY AFTER THE PROCEDURE AND WAS FOUND TO HAVE SOME FLOW STILL GOING IN BOTH ARTERIES. THE PATIENT WAS IMMEDIATELY SENT TO INTERVENTIONAL RADIOLOGY AT WHICH TIME WIRES WERE ABLE TO BE PLACED IN THE CELIAC ARTERY AND THE SUPERIOR MESENTERIC ARTERY (SMA) AND THESE VESSELS WERE STENTED. BOTH SUPERIOR MESENTERIC ARTERY (SMA) AND CELIAC ARTERIES WERE FOUND TO BE OCCLUDED WITH CLOT. THE PATIENT WAS STABLE AND PLACED IN THE INTENSIVE CARE UNIT (ICU). THE NEXT DAY A DECISION WAS MADE TO WITHDRAW CARE AND THE PATIENT DECEASED. THE PATIENT HAD BEEN INFORMED THEY WERE NOT A CANDIDATE FOR AN OPEN SURGICAL PROCEDURE, AND THAT DOING A FENESTRATED ENDOGRAFT PROCEDURE CAME WITH ELEVATED RISKS DUE TO PRE-EXISTING CONDITIONS AND LIMITED OPTIONS.

  Patient problems: Death

  MAUDE report 8494225 ↗
• MalfunctionOct 16, 2018Device Misassembled During Manufacturing /Shipping

  THE DEVICE WAS BUILT INCORRECTLY. THE DIMENSIONS DID NOT MATCH THE SPECIFICATIONS ON THE ORDER FORM. UPON INSPECTION OF THE GRAFT AND COMPARISON OF THE E#, IT WAS NOTICED AFTER LOOKING AT THE PAPERWORK IN THE BOX FOR THE GRAFT THAT THE FENESTRATIONS THAT WERE REQUESTED BY THE PHYSICIAN ON THE ORDER FORM WERE NOT THE ONES THAT WERE ON THE PAPERWORK IN THE BOX. THE CASE WAS PAUSED. THE INFORMATION WAS CROSS REFERENCED WITH THE SURGEON AND IT WAS CONFIRMED THAT THE HEALTHCARE FACILITY DID NOT RECEIVE A GRAFT WITH THE MAKEUP THAT WAS REQUESTED. THE CASE WAS THEN CANCELLED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7972030 ↗
• InjuryJan 14, 2018Leak/Splash; Material Separation

  AFTER THE AORTA WAS REMODELED, THE TWO GRAFTS PULLED APART CAUSING A TYPE 3 ENODLEAK.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7188710 ↗

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-3150-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48473, 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.
• Z-3151-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-22-73-ZT, REF G48474, 16Fr ID/ 6.0 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-3135-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-30-82-ZT, REF G48422, 20 Fr ID/ 7.7 mm OD
• 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-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-3146-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-18-73-ZT, REF G48466, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3158-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-32-39, REF G32184, 20 Fr. ID/ 7.7 mm OD, Sterile.
• Z-3136-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-32-82-ZT, REF G48427, 20 Fr ID/ 7.7 mm OD, Sterile.
• Z-3149-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-90-ZT, REF G48471, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3147-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48469, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3131-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-24-96-ZT, REF G48408, 18 Fr ID/ 7.1 mm OD, Sterile
• Z-3155-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-24-90-ZT, REF G48479, 16 Fr. ID/ 6.0 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.

…and 96 more.