Zenith G32543Recalls & reported problems
William A. Cook Australia Pty. Ltd. · Zenith Fenestrated, AAA Endovascular Graft, Proximal Body · Class 3 · Implant
All models of Zenith (32)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 6
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10827002325439), received between Mar 8, 2017 and Jan 20, 2026 — classified as 6 deaths, 9 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (2 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem6
- Appropriate Device Problem Term/Code Not Available2
- Difficult to Insert2
- Leak/Splash2
- Material Split, Cut or Torn2
- Defective Component1
- Defective Device1
- Detachment of Device or Device Component1
Patient problems
- No Code Available5
- Clinical Endoleak3
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Death2
- Multiple Organ Dysfunction Syndrome2
- Obstruction/Occlusion2
- Insufficient Information1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
InjuryJan 20, 2026Leak/Splash
IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WHERE A ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY, G32543, ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY, G32551, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, G55226, AND ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, G55243, WERE USED. AT COMPLETION OF THE PROCEDURE THERE APPEARS TO BE NUMEROUS TYPE 3 ENDOLEAKS IN THE ZFEN-P AND THE ZSLE LIMBS. THE MEDICAL DIRECTOR PERFORMED A PRELIMINARY REVIEW OF THE IMAGING PROVIDED AND CONFIRMED THE PRESENCE OF A TYPE IIIA ENDOLEAK THAT APPEARS TO BE SMALL ENOUGH TO SETTLE SPONTANEOUSLY ONCE THE HEPARIN IS REVERSED OR WEAR OFF.
Patient problems: Clinical Endoleak
MAUDE report 24116299 ↗InjuryApr 8, 2025Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Adverse Event Without Identified Device or Use Problem
PER EMAIL FROM REP - I JUST FILLED OUT A COMPLAINT FORM FOR A SURGEON IN MY TERRITORY. WE WERE PERFORMING A FENESTRATED EVAR AND HAD TO CONVERT TO OPEN REPAIR DUE TO FAILURE TO CANNULATING EITHER RENAL ARTERY. I CAN SHARE THE PATIENT SCAN ON SECURE SHUTTLE IF YOU PROVIDE AN EMAIL ADDRESS OR CONTACT TO SHARE WITH. PATIENT IS STILL UNDERGOING SURGERY AS OF THIS EMAIL, I¿M JUST GETTING IN FRONT OF THIS PROCESS. PER COMPLAINT FORM FROM REP - STANDARD ACCESS WAS USED FOR ZFEN PROCEDURE. 20FR X 25 COOK SHEATH WAS PLACED IN PATIENT RIGHT GROIN ALONG WITH A MARKING CATHETER, 7FR STEERABLE SHEATH, AND 6FR HF ANSEL SHEATH (STRAIGHT). DOCTOR CANNULATED THE RIGHT RENAL AND INFLATED A 3MM ANGIOPLASTY BALLOON TO TREAT STENOSIS. A 20FR DILATOR WAS PLACED IN THE LEFT GROIN. COOK FENESTRATED DEVICE WAS FLUSHED AND PREPPED ON THE BACK TABLE. AN AORTAGRAM WAS COMPLETED USING THE 5FR MARKING CATHETER. THE DILATOR IN THE LEFT GROIN WAS REMOVED AND THE CUSTOM MADE FENESTRATED DEVICE WAS PLACED INTO THE PATIENT'S ABDOMINAL AORTA. ORIENTATION WAS CHECKED BY REP AND SURGEON AND THEN DEPLOYMENT BEGAN. THE DEVICE HAD GREAT ORIENTATION USING THE CROSSHAIR MARKERS ON THE GRAFT. PROXIMAL DISTAL LOCATION WAS COR
Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion
MAUDE report 21799066 ↗MalfunctionApr 7, 2025Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Adverse Event Without Identified Device or Use Problem
STANDARD ACCESS WAS USED FOR ZFEN PROCEDURE. 20FR X 25 COOK SHEATH WAS PLACED IN PATIEN'T RIGHT GROIN ALONG WITH A MARKING CATHETER, 7FR STEERABLE SHEATH, AND 6FR HF ANSEL SHEATH (STRAIGHT). THE PHYSICIAN CANNULATED THE RIGHT RENAL AND INFLATED A 3MM ANGIOPLASTY BALLOON TO TREAT STENOSIS. A 20FR DILATOR WAS PLACED IN THE LEFT GROIN. COOK FENESTRATED DEVICE WAS FLUSHED AND PREPPED ON THE BACK TABLE. AN AORTAGRAM WAS COMPLETED USING THE 5FR MARKING CATHETER. THE DILATOR IN THE LEFT GROIN WAS REMOVED AND THE CUSTOM MADE FENESTRATED DEVICE WAS PLACED INTO THE PATIENT'S ABDOMINAL AORTA. ORIENTATION WAS CHECKED BY REP AND SURGEON AND THEN DEPLOYMENT BEGAN. THE DEVICE HAD GREAT ORIENTATION USING THE CROSS-HAIR MARKERS ON THE GRAFT. PROXIMAL DISTAL LOCATION WAS CORRECTED AS THE DEVICE WAS SLOWLY DEPLOYED COMPLETELY. THE PHYSICIAN THEN CANNULATED THE DISTAL BODY WITH A WIRE/CATHETER AND CONFIRMED HE WAS INSIDE THE GRAFT. THEY BEGAN TO ATTEMPT TO CANNULATE THE RIGHT RENAL FIRST. THEY WERE ABLE TO GET THE SHEATH/CATHETER/WIRE COMBINATION THROUGH THE FENESTRATION BUT HAD NO LUCK ACTUALLY CANNULATING THE RIGHT RENAL. MULTIPLE ATTEMPTS WERE MADE WITH NO SUCCESS. THEY THEN SWITCH TO ATTEMPT AT CA
Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion
MAUDE report 21782790 ↗DeathApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED: (B)(4): DUE TO LENGTH OF PROCEDURE & OCCLUSION TO RENAL ARTERIES, PATIENT¿S POTASSIUM INCREASED. PATIENT WAS PLACED ON DIALYSIS. THIS IS BELIEVED TO HAVE CAUSED LIVER FAILURE. UPON SECONDARY CAT SCAN, POST PROCEDURE, IT WAS BELIEVED THAT THE SMA AND CELIAC HAD LIMITED FLOW. PHYSICIAN PLACED STENTS IN EACH (SMA, CELIAC) TO IMPROVE BLOOD FLOW. THE CAUSE IS UNDETERMINED. PHYSICIAN STATED SHE FELT IT WAS NOT DEVICE RELATED. UPON FOLLOW UP CONVERSATION WITH THE PHYSICIAN ON (B)(6) 2023 ¿ [DISTRICT MANAGER] WAS NOTIFIED OF THE ADDITIONAL INTERVENTIONS AND THE PATIENT HAD GONE INTO ORGAN FAILURE AND EXPIRED. THIS (B)(4): DURING REVIEW OF VIDEO RECEIVED FOR THE RELATED (B)(4); AN ENDOLEAK WAS NOTED BY MEDICAL DIRECTOR.
Patient problems: Clinical Endoleak
MAUDE report 19053741 ↗DeathMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED: PR(B)(4): DUE TO LENGTH OF PROCEDURE & OCCLUSION TO RENAL ARTERIES, PATIENT¿S POTASSIUM INCREASED. PATIENT WAS PLACED ON DIALYSIS. THIS IS BELIEVED TO HAVE CAUSED LIVER FAILURE. UPON SECONDARY CAT SCAN, POST PROCEDURE, IT WAS BELIEVED THAT THE SMA AND CELIAC HAD LIMITED FLOW. PHYSICIAN PLACED STENTS IN EACH (SMA, CELIAC) TO IMPROVE BLOOD FLOW. THE CAUSE IS UNDETERMINED. PHYSICIAN STATED SHE FELT IT WAS NOT DEVICE RELATED. UPON FOLLOW UP CONVERSATION WITH THE PHYSICIAN ON (B)(6) 2023 ¿ [DISTRICT MANAGER] WAS NOTIFIED OF THE ADDITIONAL INTERVENTIONS AND THE PATIENT HAD GONE INTO ORGAN FAILURE AND EXPIRED. THIS PR(B)(4): DURING REVIEW OF VIDEO RECEIVED FOR THE RELATED PR(B)(4); AN ENDOLEAK WAS NOTED BY MEDICAL DIRECTOR.
Patient problems: Clinical Endoleak
MAUDE report 18966714 ↗DeathJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD A ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY IMPLANTED. DUE TO LENGTH OF PROCEDURE & OCCLUSION TO RENAL ARTERIES, PATIENT¿S POTASSIUM LEVELS INCREASED. THE PATIENT WAS PLACED ON DIALYSIS WHICH IS BELIEVED TO HAVE CAUSED LIVER FAILURE. UPON SECONDARY CAT SCAN PERFORMED POST PROCEDURE, IT WAS BELIEVED THAT THE SUPERIOR MESENTERIC ARTERY (SMA) AND CELIAC ARTERY HAD LIMITED FLOW. THE PHYSICIAN PLACED STENTS IN EACH (SMA AND CELIAC ARTERY) TO IMPROVE THE BLOOD FLOW. THE CAUSE IS UNDETERMINED BUT THE PHYSICIAN STATED SHE DID NOT CONSIDER IT TO BE DEVICE RELATED. UPON FOLLOW UP CONVERSATION WITH THE PHYSICIAN ON (B)(6) 2023, THE DISTRICT MANAGER WAS NOTIFIED OF THE ADDITIONAL INTERVENTIONS AND THAT THE PATIENT HAD GONE INTO ORGAN FAILURE AND EXPIRED.
Patient problems: Multiple Organ Dysfunction Syndrome
MAUDE report 18510885 ↗DeathDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD A ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY IMPLANTED. DUE TO LENGTH OF PROCEDURE & OCCLUSION TO RENAL ARTERIES, PATIENT¿S POTASSIUM LEVELS INCREASED. THE PATIENT WAS PLACED ON DIALYSIS WHICH IS BELIEVED TO HAVE CAUSED LIVER FAILURE. UPON SECONDARY CAT SCAN PERFORMED POST PROCEDURE, IT WAS BELIEVED THAT THE SUPERIOR MESENTERIC ARTERY (SMA) AND CELIAC ARTERY HAD LIMITED FLOW. THE PHYSICIAN PLACED STENTS IN EACH (SMA AND CELIAC ARTERY) TO IMPROVE THE BLOOD FLOW. THE CAUSE IS UNDETERMINED BUT THE PHYSICIAN STATED SHE DID NOT CONSIDER IT TO BE DEVICE RELATED. UPON FOLLOW UP CONVERSATION WITH THE PHYSICIAN ON (B)(6) 2023, THE DISTRICT MANAGER WAS NOTIFIED OF THE ADDITIONAL INTERVENTIONS AND THAT THE PATIENT HAD GONE INTO ORGAN FAILURE AND EXPIRED.
Patient problems: Multiple Organ Dysfunction Syndrome
MAUDE report 18407318 ↗MalfunctionOct 12, 2023Defective Device; Physical Resistance/Sticking; Defective Device; Physical Resistance/Sticking
THE SAFETY WIRE WASN'T COMING OUT AND WAS DIFFICULT TO RELEASE. UPON REMOVING THE BLACK TRIGGER WIRE, IT WOULD NOT RELEASE. THE MORE IT WAS PULLED ON, IT WOULD CAUSE THE GRAFT TO START TO COLLAPSE. THEN, THE PIN DEVICE ON THE SYSTEM WAS RELEASED AND ADVANCED THE INNER CANNULA UP IN ORDER TO REMOVE THE BLACK TRIGGER WIRE. THERE WAS NO HARM TO PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17920203 ↗MalfunctionJun 27, 2023Positioning Failure; Material Twisted/Bent; Positioning Failure; Material Twisted/Bent
EVERYTHING LOOKED CORRECT ON THE BUILD SHEET. BILATERAL PERCUTANEOUS ACCESS WAS GOTTEN. THE GRAFT WAS NOT ALTERED PRIOR TO IMPLANT. DEVICE WAS PREPPED NORMALLY AND NOTHING OF CONCERN WAS NOTED ABOUT THE APPEARANCE OF THE DEVICE. THE PHYSICIAN ORIENTED THE DEVICE OUTSIDE THE BODY BASED ON THE ANTERIOR/POSTERIOR MARKERS AND THE LOWEST RENAL (LRA AT A CLOCK POSITION OF 3:15). ORIENTATION WAS STILL CORRECT. SOME MILD TORTUOSITY DISTAL TO RENAL ARTERIES NOTED, THE LRA (LEFT RENAL ARTERY) WAS SIGNIFICANTLY LOWER. THEY BROUGHT THE DEVICE UP OVER A LUNDERQUIST WIRE AND LRA MARKERS WERE LOWER. ANTERIOR MARKERS WERE CORRECT- CONFIRMED BY ROTATION IN THE BODY AND LATERAL VIEW SHOWING ANTERIOR MARKS ANTERIOR. THE LRA LOWEST MARKER WAS ALSO APPEARING ON PATIENT LEFT . SMA AND RRA (12:30/ 10:15 AS CLOCK POSITIONS) LOOKED RIGHT ON TOP OF EACH OTHER (NORMALLY THEY LOOK MORE DIFFERENTIATED IF THEY ARE SPACED AT 2 HOURS APART). THEY BEGAN UNSHEATHING THE FIRST STENT. EVERYTHING WAS STILL OK. AS THEY UNSHEATHED THE SECOND STENT THE LRA WAS NOW ON THE RIGHT SIDE OF THE PT. AS THE STENT WAS UNSHEATHED IT APPEARED IT COMPLETELY FLIPPED 180 DEGREES. THEY ONLY HAD 2 STENTS UNSHEATHED AT THIS POINT. THEY T
Patient problems: Insufficient Information
MAUDE report 17214035 ↗InjuryJun 21, 2021Leak/Splash; Leak/Splash
A SUPPOSED TYPE III ENDOLEAK WAS FOUND ON A FOLLOW UP CTA. THE CTA AND SUBSEQUENT ANGIOGRAM SHOWS HIGHLIGHTING OF CONTRAST NEXT TO THE CONTRALATERAL GATE JUST DISTAL TO THE BIFURCATION OF THE DISTAL BODY. BECAUSE OF THE ENDOLEAK THE ANEURYSMAL SAC HAS GROWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12033840 ↗InjuryJun 9, 2021Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn
A SUPPOSED TYPE III ENDOLEAK WAS FOUND ON A FOLLOW UP CTA. THE CTA AND SUBSEQUENT ANGIOGRAM SHOWS HIGHLIGHTING OF CONTRAST NEXT TO THE CONTRALATERAL GATE JUST DISTAL TO THE BIFURCATION OF THE DISTAL BODY. BECAUSE OF THE ENDOLEAK THE ANEURYSMAL SAC HAS GROWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11963602 ↗InjuryDec 23, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE PROXIMAL AND DISTAL PIECES HAVE SEPARATED, CREATING AN ENDOLEAK. THE PHYSICIAN PLACED A BRIDGING PIECE (AN ALPHA THORACIC PIECE) TO BRIDGE THE SEPARATION SUCCESSFULLY.
Patient problems: No Code Available
MAUDE report 11065641 ↗InjuryDec 15, 2020Device Slipped; Detachment of Device or Device Component; Migration; Device Slipped; Migration
THE PROXIMAL AND DISTAL PIECES HAVE SEPARATED, CREATING AN ENDOLEAK. THE PHYSICIAN PLACED A BRIDGING PIECE (AN ALPHA THORACIC PIECE) TO BRIDGE THE SEPARATION SUCCESSFULLY.
Patient problems: No Code Available
MAUDE report 11013719 ↗InjuryNov 4, 2020Material Puncture/Hole
ZFEN WAS PLACED (B)(6) 2020. LEAK WAS THOUGHT TO BE POTENTIAL TYPE LL AND WE WOULD RE-EVALUATE. 30 DAY CT FOLLOW UP WAS PERFORMED AND SIGNIFICANT ENDOLEAK WAS STILL APPRECIATED. DIAGNOSTIC ANGIOGRAMS CONFIRMED TYPE LLL, THOUGHT TO BE TEAR OF DEFECT IN FLOW DIVIDER. PATIENT WAS RESCHEDULED TO RELINE.
Patient problems: No Code Available
MAUDE report 10787001 ↗InjuryOct 19, 2020Material Split, Cut or Torn; Defective Component; Material Split, Cut or Torn
ZFEN WAS PLACED (B)(6) 2020. LEAK WAS THOUGHT TO BE POTENTIAL TYPE LL AND WE WOULD RE-EVALUATE. 30 DAY CT FOLLOW UP WAS PERFORMED AND SIGNIFICANT ENDOLEAK WAS STILL APPRECIATED. DIAGNOSTIC ANGIOGRAMS CONFIRMED TYPE LLL, THOUGHT TO BE TEAR OF DEFECT IN FLOW DIVIDER. PATIENT WAS RESCHEDULED TO RELINE.
Patient problems: No Code Available
MAUDE report 10700421 ↗DeathDec 8, 2019Failure to Advance
UPON THE FINAL RUN, THE CELIAC AND SUPERIOR MESENTERIC ARTERY (SMA) WERE NOT VISUALIZED. MORE IMAGING WAS DONE TO SEE THE VESSELS BETTER. STILL NO VISUALIZATION. THE ARM ACCESS WAS USED TO GET IN FROM ABOVE. ONE VESSEL WAS CANNULATED, BUT A 7FR SHEATH WOULD NOT PASS INTO THE VESSEL. ACCESS WAS LOST, BUT A 6FR SHEATH WAS ADVANCED, AND ACCESS TO THE CELIAC WAS GAINED. A BARE-METAL STENT WAS DEPLOYED. THERE WERE SEVERAL TRIES TO GET INTO THE SMA, BUT ACCESS WAS NEVER GAINED. THE PHYSICIANS MADE THE DECISION TO OPEN THE ABDOMEN TO TRY TO GET A RETROGRADE STENT INTO THE SMA. PATIENT PASSED AFTER HE WAS MOVED FROM THE OPERATING ROOM TABLE.
Patient problems: Death
MAUDE report 9435153 ↗DeathDec 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING INTO THE INITIAL REPORTER, DURING A FENESTRATED ABDOMINAL ZFEN PROCEDURE, UPON THE FINAL RUN THE SMA AND CELIAC WERE NOT VISUALIZED. THE PHYSICIAN BELIEVES THE INITIAL PROCEDURE WAS CAUSE FOR AN ADDITIONAL PROCEDURE; THE PATIENT HAD TO HAVE OPEN ABDOMINAL SURGERY. (THE PATIENT¿S ABDOMEN WAS OPENED TO TRY TO STENT THE SMA RETROGRADE.) PATIENT PASSED AFTER HE WAS MOVED FROM THE OR TABLE.
Patient problems: Death
MAUDE report 9394730 ↗InjuryMar 8, 2017Material Separation
IN (B)(6) OF 2014, PROXIMAL AND DISTAL FENESTRATED DEVICES WERE IMPLANTED IN THE PATIENT WITHOUT INCIDENCE. ON FOLLOW UP CT SCAN OF (B)(6) 2016, IT WAS NOTED TO HAVE COMPONENT SEPARATION OF THE PROXIMAL BODY AND DISTAL BODY. ON (B)(6) 17, A DEVICE WAS USED TO BRIDGE THE TWO COMPONENTS BACK TOGETHER. A SECOND ADDITIONAL DEVICE WAS THEN PLACED FOR ADDITIONAL RADIAL FORCE BETWEEN THE PROXIMAL AND DISTAL TO HOPEFULLY KEEP IT FROM SEPARATING AGAIN.
Patient problems: No Code Available
MAUDE report 6390245 ↗
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-3136-2011 · Apr 15, 2011 · TerminatedCook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-32-82-ZT, REF G48427, 20 Fr ID/ 7.7 mm OD, Sterile.
- Z-3155-2011 · Apr 15, 2011 · TerminatedCook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-24-90-ZT, REF G48479, 16 Fr. ID/ 6.0 OD, Sterile.
- Z-3156-2011 · Apr 15, 2011 · TerminatedCook Medical Zenith Flex AAA Main Body Extension, REF ESBE-22-29, REF G32179, 18 Fr. ID/ 6.90 OD, Sterile.
- Z-3138-2011 · Apr 15, 2011 · TerminatedCook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-36-95-ZT, REF G48432, 22 Fr ID/ 8.5 mm OD, Sterile.
- Z-3140-2011 · Apr 15, 2011 · TerminatedCook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-12-56-ZT, REF G48449, 16Fr ID/ 6.0 mm OD, Sterile.
- Z-3152-2011 · Apr 15, 2011 · TerminatedCook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-73-ZT, REF G48476, 16Fr ID/ 6.0 mm OD, Sterile.
- Z-3137-2011 · Apr 15, 2011 · TerminatedCook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-32-96-ZT, REF G48428, 20 Fr ID/ 7.7 mm OD, Sterile.
- Z-3158-2011 · Apr 15, 2011 · TerminatedCook Medical Zenith Flex AAA Main Body Extension, REF ESBE-32-39, REF G32184, 20 Fr. ID/ 7.7 mm OD, Sterile.
- Z-3146-2011 · Apr 15, 2011 · TerminatedCook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-18-73-ZT, REF G48466, 16Fr ID/ 6.0 mm OD, Sterile.
- Z-3133-2011 · Apr 15, 2011 · TerminatedCook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-26-125-ZT, REF G48415, 18 Fr ID/ 7.1 mm OD, Sterile.
- Z-3134-2011 · Apr 15, 2011 · TerminatedCook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-28-96-ZT, REF G48418, 20 Fr ID/ 7.7 mm OD, Sterile
- Z-3143-2011 · Apr 15, 2011 · TerminatedCook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-73-ZT, REF G48462, 16Fr ID/ 6.0 mm OD, Sterile.
- Z-3148-2011 · Apr 15, 2011 · TerminatedCook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-73-ZT, REF G48470, 16Fr ID/ 6.0 mm OD, Sterile.
- Z-3130-2011 · Apr 15, 2011 · TerminatedCook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-24-82-ZT, REF G48407, 18 Fr ID/ 7.1 mm OD, Sterile
- Z-3144-2011 · Apr 15, 2011 · TerminatedCook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-90-ZT, REF G48463, 16Fr ID/ 6.0 mm OD, Sterile.
…and 96 more.
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- Endurant® IIs ESBF2514C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls18 deaths136 reports
- Endurant® IIs ESBF2314C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls9 deaths60 reports
- RelayPro Thoracic Stent-Graft System 28-N4-34-154-34UBolton Medical Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment3 recalls7 reports
- Vela Proximal Endograft System A34-34/C100-O20 VEndologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment3 deaths152 reports
- Endurant® II ETCF2828C49EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls7 deaths44 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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