Zenith G32551Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10827002325514), received between Feb 23, 2017 and Feb 2, 2026 — classified as 5 deaths, 37 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2026Leak/Splash; Migration

  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 24231087 ↗
• 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 24115742 ↗
• InjuryJan 9, 2026Material Integrity Problem

  A ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY WAS IMPLANTED ON (B)(6) 2025. ON AN UNKNOWN DATE AN ANGIOGRAM WAS PERFORMED AND A TYPE 3 ENDOLEAK (TEAR OF FABRIC OF THE DEVICE) WAS DISCOVERED. THE TYPE 3 ENDOLEAK WAS REPORTED TO THE DISTRICT MANAGER ON (B)(6) 2025. THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Clinical Endoleak

  MAUDE report 24020890 ↗
• InjuryDec 22, 2025Material Split, Cut or Torn; Device Endoleak; Material Split, Cut or Torn; Device Endoleak

  A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A GRAFT IMPLANT PROCEDURE IN WHICH THE ZENITH BIFURCATED BODY GRAFT WAS USED. IT WAS STATED THERE WAS A POSSIBLE TEAR IN THE BIFURCATION OF THE DEVICE. THE FOLLOWING FURTHER INFORMATION WAS PROVIDED: THE PROXIMAL GRAFT WAS PLACED IN ACCORDANCE TO THE IFU; BALLOONING OF THE PROXIMAL GRAFT WITH A 32 CODA BALLOON, BILATERAL RENAL STENTING WITH GORE VIABAHN VBX STENTS, BALLOONING OF RENAL STENTS WITH A MUSTANG 10X2 BALLOON. PLACEMENT OF THE DISTAL GRAFT WAS IN ACCORDANCE TO THE IFU. PLACEMENT OF A ZSLE 16 LIMB IN THE PATIENT¿S LEFT ILIAC. PLACEMENT OF A ZSLE 16 IN THE PATIENT¿S RIGHT ILIAC. BALLOONING OF BOTH THE PROXIMAL AND DISTAL BODY USING A 32 CODA BALLOON. BALLOONING OF PROXIMAL OVERLAP OF THE ZSLES WITH DISTAL BODY AND ILIACS USING A 32 CODA BALLOON. PLACEMENT OF A 26 ESBE AT PROXIMAL AND DISTAL BODY OVERLAP WHEN ENDOLEAK APPEARED ON ANGIOGRAM. RE-BALLOON OF THE PROXIMAL AND DISTAL BODY OVERLAP WHERE THE ESBE WAS PLACED.

  Patient problems: Clinical Endoleak

  MAUDE report 23861677 ↗
• InjuryDec 22, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  DURING A GRAFT IMPLANT PROCEDURE, A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN UNSPECIFIED PROCEDURE IN WHICH THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATION BODY, G32551 WAS USED. IT WAS REPORTED THAT THE CASE WENT AS NORMAL. DURING ANGIOGRAM TAKEN AT THE END OF THE PROCEDURE, THE PHYSICIAN CONFIRMED THE GRAFT LOOKED GOOD IN PLACE, AND THE OVERLAP WAS GOOD. WHEN THE PHYSICIAN DID A FINAL RUN, THE PHYSICIAN FELT LIKE THERE WAS A LEAK. THE PHYSICIAN BALLOONED AGAIN AND STILL FELT THERE WAS A LEAK. THE PHYSICIAN TROUBLESHOT AND FELT THE LEAK WAS WITH THE GRAFT ITSELF. THE GRAFT REMAINS IMPLANTED; THE PHYSICIAN DID NOT REINTERVENE AND WILL DO A FOLLOW-UP IN THIRTY DAYS. FURTHER DETAILS OF THE PROCEDURE REVEALED THAT THE PROXIMAL GRAFT WAS PLACED IN ACCORDANCE WITH THE IFU; BALLOONING OF PROXIMAL GRAFT WITH A 32 CODA BALLOON, BILATERAL RENAL STENTING WITH GORE VIABAHN VBX STENTS, BALLOONING OF RENAL STENTS WITH A MUSTANG 10X2 BALLOON. PLACEMENT OF THE DISTAL GRAFT WAS IN ACCORDANCE TO IFU. PLACEMENT OF A ZSLE 13 LIMB TO EXTEND AND BRIDGE ZSLE 24 IN PATIENT¿S LEFT ILIAC. PLACEMENT OF A ZSLE 20 IN PATIENT¿S RIGHT ILIAC. BALLOONING OF BOTH PROXIMAL AND DISTAL BODY

  Patient problems: Clinical Endoleak

  MAUDE report 23861670 ↗
• InjuryDec 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN UNSPECIFIED PROCEDURE IN WHICH THE ZENITH BIFURCATED BODY GRAFT WAS USED. IT WAS FURTHER STATED THERE WAS A POSSIBLE TEAR IN THE BIFURCATION. THE FOLLOWING FURTHER INFORMATION WAS PROVIDED REGARDING THE PROCEDURE. THE PROXIMAL GRAFT WAS PLACED IN ACCORDANCE TO IFU, BALLOONING OF PROXIMAL GRAFT WITH A 32 CODA BALLOON, BILATERAL RENAL STENTING WITH GORE VIABAHN VBX STENTS, BALLOONING OF RENAL STENTS WITH A MUSTANG 10X2 BALLOON, PLACEMENT OF DISTAL GRAFT IN ACCORDANCE TO IFU, PLACEMENT OF ZSLE 16 LIMB IN PATIENT¿S LEFT ILIAC, PLACEMENT OF ZSLE 16 IN PATIENT¿S RIGHT ILIAC, BALLOONING OF PROXIMAL AND DISTAL BODY USING A 32 CODA BALLOON, BALLOONING OF PROXIMAL OVERLAP OF ZSLES WITH DISTAL BODY AND ILIACS USING A 32 CODA BALLOON, PLACEMENT OF 26 ESBE AT PROXIMAL AND DISTAL BODY OVERLAP WHEN ENDOLEAK APPEARED ON ANGIOGRAM, RE-BALLOON OF PROXIMAL AND DISTAL BODY OVERLAP WHERE ESBE WAS PLACED.

  Patient problems: Clinical Endoleak

  MAUDE report 23787970 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A GRAFT IMPLANT PROCEDURE, A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN UNSPECIFIED PROCEDURE IN WHICH THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATION BODY, G32551 WAS USED. IT WAS REPORTED THE CASE WENT AS NORMAL. DURING THE ENDING ANGIOGRAM, THE PHYSICIAN CONFIRMED THE GRAFT LOOKED GOOD IN PLACE, THE OVERLAP WAS GOOD. WHEN THE PHYSICIAN DID A FINAL RUN, THE PHYSICIAN FELT LIKE THERE WAS A LEAK. THE PHYSICIAN BALLOONED AGAIN AND STILL FELT THERE WAS A LEAK. PHYSICIAN TROUBLESHOOTED AND FELT THE LEAK WAS WITH THE GRAFT ITSELF. THE GRAFT REMAINS IMPLANTED; THE PHYSICIAN DID NOT REINTERVENE AND WILL DO A FOLLOW-UP IN THIRTY DAYS. FURTHER DETAILS OF THE PROCEDURE REVEAL THE PROXIMAL GRAFT WAS PLACED IN ACCORDANCE TO IFU, BALLOONING OF PROXIMAL GRAFT WITH A 32 CODA BALLOON, BILATERAL RENAL STENTING WITH GORE VIABAHN VBX STENTS, BALLOONING OF RENAL STENTS WITH A MUSTANG 10X2 BALLOON, PLACEMENT OF DISTAL GRAFT IN ACCORDANCE TO IFU, PLACEMENT OF ZSLE 13 LIMB TO EXTEND AND BRIDGE ZSLE 24 IN PATIENT¿S LEFT ILIAC, PLACEMENT OF ZSLE 20 IN PATIENT¿S RIGHT ILIAC, BALLOONING OF PROXIMAL AND DISTAL BODY USING A 32 CODA BALLOON, BALLOONING OF PROXIMAL OVERLAP OF ZSL

  Patient problems: Insufficient Information

  MAUDE report 23778960 ↗
• InjuryNov 24, 2025Device Endoleak; Device Endoleak

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ORIGINAL IMPLANT PROCEDURE DURING WHICH SEVERAL I-CAST STENTS WERE PLACED, INCLUDING COVERED STENTS IN THE RENAL ARTERIES THROUGH SMALL FENESTRATIONS (SIZES: I-CAST 6X22 MM ON THE RIGHT AND 7X22 MM ON THE LEFT, WITH 5-7 MM OVERLAP INSIDE THE AORTA). THE NECK ANATOMY WAS PARALLEL, AND BALLOONING WAS PERFORMED AT ALL CONTRALATERAL JUNCTION POINTS, USING A 10X2 BALLOON TO FLARE THE INTRA-AORTIC SEGMENT OF THE COVERED STENT. ALTHOUGH THE DEVICE WAS INSPECTED PRIOR TO USE AND THE INSTRUCTIONS FOR USE (IFU) WERE FOLLOWED, A COMPLETION ANGIOGRAM REVEALED AN ENDOLEAK AT THE DISTAL END IN THE BIFURCATED ABDOMINAL AORTA, RAISING CONCERNS ABOUT A POTENTIAL CROTCH TEAR AT THE BIFURCATION. APPROXIMATELY 30 DAYS LATER, A FOLLOW-UP SCAN CONFIRMED THE PRESENCE OF AN ENDOLEAK, WHICH WAS IDENTIFIED AS A TYPE III ENDOLEAK BETWEEN THE DISTAL GRAFT AND LEG GRAFT. THE PATIENT REQUIRED REINTERVENTION, AND A COMPLETION GRAFT WAS REINTRODUCED TO REALIGN THE ORIGINAL GRAFT, FOLLOWED BY POST-IMPLANTATION RE-BALLOONING. THE PHYSICIAN, AFTER REVIEWING THE CASE, BELIEVED THAT AGGRESSIVE BALLOONING MAY HAVE CONTRIBUTED TO THE PROBLEM. NO ADVERSE EVENTS WERE REPORTED, AND AL

  Patient problems: Clinical Endoleak

  MAUDE report 23631597 ↗
• MalfunctionMay 1, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  WHEN RELEASING THE DISTAL END OF THE GRAFT, THE RELEASE MECHANISM CAME OFF BUT THE WIRE DID NOT. FORCEPS WERE USED TO REMOVE WIRE AND THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19227057 ↗
• MalfunctionFeb 12, 2024Fracture; Defective Component; Fracture; Defective Component

  THE PLACEMENT WENT FINE, IT WAS DURING THE REMOVAL OF THE DEVICE IS WHEN IT WAS NOTICED THAT THE DISTAL TRIGGER THUMBSCREW APPEARED TO BE SHEARED OFF. A SAW HAD TO BE USED TO CUT THE TRIGGER WIRE IN HALF TO REMOVE THE DISTAL WIRE. NO HARM TO PATIENT. REPORTER ADVISED THAT IT DOES NOT SEEM THAT THE DEVICE INSPECTED PRIOR TO USE IN ORDER TO ENSURE NO DAMAGE HAD OCCURRED; DUE TO THE THUMBSCREW BEING SHEARED OFF. REPORTER WAS UNABLE TO CONFIRM THAT THE THUMBSCREWS WERE IN PLACE. (WHEN ASKED IF THE THUMB SCREWS (RMTS) WERE ALIGNED AT 12 O¿CLOCK, AND WERE ALIGNED WITH THE ANTERIOR GOLD MARKERS.) THE TRIGGER WIRE RELEASED WITH THE USE OF A SAW TO CUT THE WHITE PIECE IN HALF AND PULL THE TRIGGER. THE ALTERNATIVE TRIGGER WIRE RELEASE METHOD WAS UTILIZED AS PER LABELLING, BUT 'IT WOULD NOT BUDGE'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18692514 ↗
• InjuryDec 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 MI OR CARDIAC ARREST. THE PHYSICIAN BELIEVES PATIENT DEATH WAS NOT CAUSED BY THE IMPLANTED DEVICE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15927778 ↗
• 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 15912599 ↗
• DeathMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH RENAL FAILURE AND ABDOMINAL PAIN. IT WAS DECIDED NOT TO PURSUE DIALYSIS. THE PATIENT DIED SEVERAL DAYS LATER.

  Patient problems: Abdominal Pain; Renal Failure

  MAUDE report 14316400 ↗
• DeathApr 28, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH RENAL FAILURE AND ABDOMINAL PAIN. IT WAS DECIDED NOT TO PURSUE DIALYSIS. THE PATIENT DIED SEVERAL DAYS LATER.

  Patient problems: Abdominal Pain; Renal Failure

  MAUDE report 14231759 ↗
• InjuryApr 22, 2022Material Separation; Material Separation

  APPROXIMATELY THREE YEARS POST IMPLANT, THE BIFURCATED GRAFT SEPARATED FROM THE TUBE GRAFT. THE PHYSICIAN HAD TO RELINE THE ENDOGRAFT.

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

  MAUDE report 14187042 ↗
• InjuryApr 6, 2022Migration; Material Separation; Migration

  APPROXIMATELY THREE YEARS POST IMPLANT, THE BIFURCATED GRAFT SEPARATED FROM THE TUBE GRAFT. THE PHYSICIAN HAD TO RELINE THE ENDOGRAFT.

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

  MAUDE report 14018502 ↗
• InjuryDec 18, 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 11035919 ↗
• InjuryDec 17, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT THE END OF THE PROCEDURE THE PHYSICIAN LOOKED AT THE GRAFT AND NOTED A LEAK AND PLACED A CUFF GRAFT WHICH WORKED. AT THE ONE MONTH FOLLOW UP A TYPE III ENDOLEAK WAS NOTED AT WHAT APPEARS TO BE THE CROTCH AREA OF THE GRAFT. THE PHYSICIAN WILL SCHEDULE A REPAIR PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 11029926 ↗
• InjuryDec 16, 2020Leak/Splash; Material Separation; Device Slipped; 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 11020804 ↗
• InjuryDec 9, 2020Leak/Splash; Material Split, Cut or Torn; Material Split, Cut or Torn

  AT THE END OF THE PROCEDURE THE PHYSICIAN LOOKED AT THE GRAFT AND NOTED A LEAK AND PLACED A CUFF GRAFT WHICH WORKED. AT THE ONE MONTH FOLLOW UP A TYPE III ENDOLEAK WAS NOTED AT WHAT APPEARS TO BE THE CROTCH AREA OF THE GRAFT. THE PHYSICIAN WILL SCHEDULE A REPAIR PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 10977525 ↗
• DeathSep 10, 2020Material Separation; Material Separation

  ACCORDING TO THE INITIAL REPORTER: "FENESTRATED SYSTEMS ARE SUPPOSED TO OVERLAP. THE DEVICE CAME DISCONNECTED OVER THE PAST FEW YEARS, PATIENT DIED IN (B)(6). ONE DEVICE MIGRATED, NOT CONFIRMED BUT INITIAL REPORTER SPECULATES THAT DISTAL PIECE IS MORE LIKELY TO HAVE MIGRATED. CUSTOMER ALLEGING THAT DISCONNECTING WAS A CONTRIBUTING FACTOR. PATIENT PRESENTED TO ER WITH BELLY PAIN AT (MEDICAL FACILITY), CT SCAN PERFORMED THAT OBSERVED A RUPTURE, PATIENT WAS TRANSPORTED TO (MEDICAL FACILITY), FACILITY TRIED TO REPAIR DISCONNECTION, AND PATIENT DIED FROM COMPLICATIONS SUBSEQUENT TO THE ATTEMPT TO REPAIR. SUBSEQUENT TO REPAIR, PATIENT DEVELOPED COMPARTMENT SYNDROME AND PATIENT'S FAMILY DECLINED TO HAVE PATIENT GO BACK TO SURGERY." IT WAS REPORTED THAT THE PATIENT EXPIRED.

  Patient problems: Death

  MAUDE report 10515247 ↗
• DeathAug 26, 2020Device Slipped; Detachment of Device or Device Component; Migration; Device Slipped

  ACCORDING TO THE INITIAL REPORTER: "FENESTRATED SYSTEMS ARE SUPPOSED TO OVERLAP. THE DEVICE CAME DISCONNECTED OVER THE PAST FEW YEARS, PATIENT DIED ON (B)(6). ONE DEVICE MIGRATED, NOT CONFIRMED BUT INITIAL REPORTER SPECULATES THAT DISTAL PIECE IS MORE LIKELY TO HAVE MIGRATED. CUSTOMER ALLEGING THAT DISCONNECTING WAS A CONTRIBUTING FACTOR. PATIENT PRESENTED TO ER WITH BELLY PAIN AT (MEDICAL FACILITY), CT SCAN PERFORMED THAT OBSERVED A RUPTURE, PATIENT WAS TRANSPORTED TO (MEDICAL FACILITY), FACILITY TRIED TO REPAIR DISCONNECTION, AND PATIENT DIED FROM COMPLICATIONS SUBSEQUENT TO THE ATTEMPT TO REPAIR. SUBSEQUENT TO REPAIR, PATIENT DEVELOPED COMPARTMENT SYNDROME AND PATIENT'S FAMILY DECLINED TO HAVE PATIENT GO BACK TO SURGERY." IT WAS REPORTED THAT THE PATIENT EXPIRED.

  Patient problems: Death

  MAUDE report 10455603 ↗
• InjuryJun 7, 2020Migration; Leak/Splash; Material Separation; Migration

  THE PROXIMAL GRAFT AND THE DISTAL GRAFT SEPARATED CREATING A TYPE 3 ENDOLEAK. SURGICAL INTERVENTION WAS REQUIRED. THE DISTAL FENESTRATED COMPONENT LOST ITS OVERLAP WITH THE PROXIMAL FENESTRATED COMPONENT. THE DISTAL COMPONENT MIGRATED DOWN INTO THE ANEURYSM AT A DIFFICULT ANGLE POSTERIORLY. ALSO, THE RIGHT AND LEFT ILIAC LIMBS LOST SEAL WITHIN THE COMMON ILIACS AND MIGRATED UP INTO THE ANEURYSM. THE DISTAL FENESTRATED GRAFT AND LIMBS FOLDED IN THE ANEURYSM MAKING REINTERVENTION DIFFICULT. PHYSICIAN ACCESSED THE AXILLARY ARTERY AND PUT A 8FR SHEATH DOWN INTO THE AORTA. HE STENTED THE SUPERIOR MESENTERIC ARTERY WITH A GORE 8X29 VBX AND STENTED THE LEFT RENAL ARTERY WITH A GORE 6X29 VBX. HE THEN DROVE A WIRE DOWN INTO THE PROXIMAL FENESTRATED GRAFT. HE WAS ABLE TO SNAKE THE WIRE INTO THE DISTAL GRAFT AND THROUGH THE LEFT ILIAC LIMB. THE PHYSICIAN ACCESSED BOTH FEMORAL ARTERIES AND THEN FROM THE LEFT SIDE SNARED THE WIRE FROM ABOVE. ONCE HE HAD WIRE ACCESS HE EXCHANGED IT TO A STIFF WIRE WHICH HELPED STRAIGHTEN OUT THE FOLDED GRAFT. HE THEN ACCESSED THE PATIENTS RIGHT FEMORAL ARTERY WITH A WIRE AND WAS ABLE TO GET ACCESS INTO THE AORTA FROM BOTH SIDES. HE DECIDED TO RELINE THE GRAFT WI

  Patient problems: No Code Available

  MAUDE report 10126672 ↗
• InjuryJun 4, 2020Material Separation; Material Separation

  ACCORDING TO THE INITIAL REPORTER, THE PROXIMAL GRAFT AND THE DISTAL GRAFT SEPARATED CREATING A TYPE 3 ENDOLEAK. IT WAS REPORTED THAT THE PATIENT UNDERWENT INTERVENTION ON (B)(6) 2020. IT WAS FURTHER REPORTED: YES SURGICAL INTERVENTION WAS REQUIRED. THE DISTAL FENESTRATED COMPONENT LOST ITS OVERLAP WITH THE PROXIMAL FENESTRATED COMPONENT. THE DISTAL COMPONENT MIGRATED DOWN INTO THE ANEURYSM AT A DIFFICULT ANGLE POSTERIORLY. ALSO, THE RIGHT AND LEFT ILIAC LIMBS LOST SEAL WITHIN THE COMMON ILIACS AND MIGRATED UP INTO THE ANEURYSM. THE DISTAL FENESTRATED GRAFT AND LIMBS FOLDED IN THE ANEURYSM MAKING REINTERVENTION DIFFICULT. PHYSICIAN ACCESSED THE AXILLARY ARTERY AND PUT A 8FR SHEATH DOWN INTO THE AORTA. HE STENTED THE SMA WITH A GORE 8X29 VBX AND STENTED THE LEFT RENAL ARTERY WITH A GORE 6X29 VBX. HE THEN DROVE A WIRE DOWN INTO THE PROXIMAL FENENSTRATED GRAFT. HE WAS ABLE TO SNAKE THE WIRE INTO THE DISTAL GRAFT AND THROUGH THE LEFT ILIAC LIMB. THE PHYSICIAN ACCESSED BOTH FEMORAL ARTERIES AND THEN FROM THE LEFT SIDE SNARED THE WIRE FROM ABOVE. ONCE HE HAD WIRE ACCESS HE EXCHANGED IT TO A STIFF WIRE WHICH HELPED STRAIGHTEN OUT THE FOLDED GRAFT. HE THEN ACCESSED THE PATIENTS RIGHT FEMOR

  Patient problems: No Code Available

  MAUDE report 10119713 ↗
• InjuryMay 26, 2020Leak/Splash

  DURING A POST OP SCAN, AN ENDOLEAK WAS NOTED AROUND THE AORTIC BIFURCATION AND IT WAS ASSOCIATED WITH ABDOMINAL AORTIC ANEURYSM GROWTH. THE PATIENT WAS BROUGHT IN FOR A DIAGNOSTIC ANGIOGRAM AND ADDITIONAL CTA. TYPE TWO AND THREE LEAKS WERE RULED OUT AND IT WAS CONCLUDED THAT THERE WAS A TYPE FOUR LEAK AT THE BIFURCATION OF THE DISTAL GRAFT. THE SURGEON DECIDED TO RELINE THE DISTAL GRAFT WITH A FLEX DEVICE AND NEW LIMBS. HE DOES NOT WANT A CREDIT ON ANY ITEMS, IS NOT EXPLANTING ANYTHING AND IS HAPPY WITH THE FINAL RESULT, BUT WANTS IT NOTED THAT HE BELIEVES THE BIFURCATED ZFEN GRAFT HAD A POROSITY ISSUE.

  Patient problems: No Code Available

  MAUDE report 10085930 ↗

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-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-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-3142-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-56-ZT, REF G48461, 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-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-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-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-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-3145-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-18-56-ZT, REF G48465, 16Fr ID/ 6.0 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-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-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-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-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-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.

…and 96 more.