Zenith G32542Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10827002325422), received between Aug 16, 2016 and Jul 18, 2023 — classified as 1 death, 8 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2023Failure to Align; Material Twisted/Bent; Failure to Align; Material Twisted/Bent

  ON (B)(6) 2023 DR(B)(6) AND DR. (B)(6) IMPLANTED A ZFEN GRAFT. THE DEVICE WAS LOADED INTO THE SHEATH IN A WAY THAT MADE DEPLOYMENT VERY DIFFICULT. THE GRAFT WAS TWISTED WITHIN THE SHEATH. THE RIGHT RENAL ARTERY WAS ALL THE WAY ON THE LEFT SIDE OF THE SHEATH. THERE WAS NOT PROLONGED HOSPITALISATION DUE TO THE REPORTED EVENT, AND THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL SPECIALIST. IT WAS REPORTED THAT THE IFU WAS FOLLOWED. THE DEVICE WAS INSPECTED PRIOR TO USE TO ENSURE THAT NO DAMAGE HAD OCCURRED. IT WAS REPORTED THAT THE DISCREPANCY WAS IDENTIFIED DURING ORIENTATION OF THE DEVICE ON THE PATIENT'S ABDOMEN BEFORE ADVANCING UP THE PATIENT. THE ANTERIOR MARKERS WERE LOADED CLOSE TO THE INNER CANNULA MAKING IT DIFFICULT TO CONFIRM IF THEY ALIGNED WITH THE GOLD MARKERS. THE PATIENT HAD TORTUOUS ANATOMY WITH ANGULATION OF THE AORTA AND NARROWING OF THE INFRARENAL AORTA. THE PATIENT WAS PRESCRIBED HEPARIN (UNKNOWN DOSE). THERE WAS A LOT OF MANIPULATION AND ROTATION OF THE GRAFT TO GET IT TO OPEN FULLY AND CORRECTLY. THE GRAFT HAD ROTATED WITHIN THE SECOND COVERED STENT. IT WAS ROTATED BACK AND FORTH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17339764 ↗
• InjuryJun 28, 2023Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  PATIENT SEEN BY IMPLANTING PHYSICIAN, ON FIRST FOLLOW UP OF ZFEN REPAIR. NOT SYMPTOMATIC, HOWEVER HE WAS FOUND ON CT TO HAVE AN OCCLUDED LEFT ILIAC LIMB, AS WELL AS OCCLUDED RIGHT RENAL ARTERY (VBX STENT). PATIENT HAD NOT TAKEN ANY OF THEIR ASPIRIN OR PLAVIX AS ADVISED BY PATIENT CARE TEAM. PHYSICIAN DID NOTE THE ILIAC LIMB HAD SHIFTED FROM THE FINAL ANGIOGRAPHY IN THE CASE. THEY COIL EMBOLIZED AND LANDED IN THE EXTERNAL ILIAC. ILIAC WAS TORTUOUS, HOWEVER THE FINAL ANGIOGRAPHY WAS SHOT WITHOUT A STIFF WIRE, SO SHE BELIEVES THE STENT MAY BE A CONTRIBUTING FACTOR ALONG WITH THE NON-COMPLIANCE OF BLOOD THINNERS. COILING DONE (B)(6) 2023, ZFEN IMPLANTED ON (B)(6) 2023.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17222255 ↗
• MalfunctionMay 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE GRAFT WAS UNSHEATHED AFTER CANNULATION OF THE NEEDED VESSELS AND THE FIRST TRIGGER (GOLD) WAS ABOUT TO BE REMOVED TO DEPLOY DISTAL CONSTRAINING TIES. UPON COMPLETE REMOVAL OF THE WHITE KNOB, THE PHYSICIAN ATTEMPTED TO PULL THE WIRE WITH THE GOLD TRIGGER RELEASE MECHANISM. ONLY HALF OF THE GOLD MECHANISM CAME OFF WITH NO WIRE ATTACHED. THE PHYSICIAN WAS INSTRUCTED BY THE DISTRICT MANAGER TO PAUSE AND LOOK FOR THE WIRE IN THE REMAINING MECHANISM. THE WIRE WAS VISIBLE AND THE PHYSICIAN FOUND A SURGICAL CLAMP TO HOLD THE WIRE WHILE A HEAVY-DUTY NEEDLE DRIVER TO GRASP THE WIRE WAS LOCATED. THE OTHER HALF OF THE GOLD MECHANISM WAS REMOVED. THE WIRE WAS REMOVED UNDER FLUOROSCOPIC GUIDANCE WHILE OBSERVING FULL OPENING OF THE GRAFT. THERE WERE NO OTHER ISSUES WITH THE REMOVAL OF THE REMAINING TWO RELEASE MECHANISMS. SURGERY WAS COMPLETED WITH NOT ADDITIONAL ACTIONS NEEDED. THERE DOES NOT SEEM TO BE ANY SCREWS IN THE GOLD RELEASE MECHANISM THAT WOULD HOLD THE TWO PARTS TOGETHER WITH THE WIRE. THE DISTRICT MANAGER HAS INFORMED THAT THE INSTRUCTIONS FOR USE (IFU) WAS FOLLOWED. THERE WERE NO DEVIATION OR DIVERGENCE OFF THE IFU THAT CAUSED THE REPORTED EVENT. THIS OCCURRED AT THE DISTAL END

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16892978 ↗
• InjuryDec 28, 2021Obstruction of Flow; Obstruction of Flow

  ORIGINALLY STENT WAS IMPLANTED ON (B)(6) 2021. 2 ICAST STENTS WERE ALSO IMPLANTED BOTH OF 6X22, PLACED ONE ON EACH SIDE OF RENALS RESPECTIVELY (LEFT AND RIGHT). NOTICE NARROWING ON (B)(6) 2021 OF THE SUPERIOR MESENTERIC ARTERY (SMA) AND THE CELIAC ARTERY WITH DECREASED FLOW. THIS REQUIRED STENTING OF BOTH ARTERIES BUT INFORMATION OF STENTS USED IS UNKNOWN. TWISTING MAY HAVE CONTRIBUTED TO THE OCCURRED EVENT, BUT THIS CANNOT BE DETERMINED. NO TWISTING OCCURRED DURING THE ORIGINAL PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 13097849 ↗
• InjuryDec 22, 2021Obstruction of Flow; Infusion or Flow Problem; Output Problem; Obstruction of Flow

  ORIGINALLY STENT WAS IMPLANTED ON (B)(6) 2021. 2 ICAST STENTS WERE ALSO IMPLANTED BOTH OF 6X22, PLACED ONE ON EACH SIDE OF RENALS RESPECTIVELY (LEFT AND RIGHT). NOTICE NARROWING ON (B)(6) 2021 OF THE SUPERIOR MESENTERIC ARTERY (SMA) AND THE CELIAC ARTERY WITH DECREASED FLOW. THIS REQUIRED STENTING OF BOTH ARTERIES BUT INFORMATION OF STENTS USED IS UNKNOWN. TWISTING MAY HAVE CONTRIBUTED TO THE OCCURRED EVENT, BUT THIS CANNOT BE DETERMINED. NO TWISTING OCCURRED DURING THE ORIGINAL PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 13064725 ↗
• InjuryOct 26, 2021Migration; Migration

  THE PATIENT WAS DISCOVERED UNCONSCIOUS AT HOME BY A FAMILY MEMBER AND WAS BROUGHT TO THE HOSPITAL WHERE AN IMAGING PROCEDURE WAS PERFORMED. IMAGING SHOWED THAT THE ANEURYSM SAC APPEARED TO BE ENLARGED AND COMPONENT SEPARATION. THE PATIENT HAS REFUSED FURTHER TREATMENT. REVIEW OF IMAGING SUPPLIED SHOWS A SEPARATION BETWEEN A ZFEN-D AND ZFEN-P GRAFTS.

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

  MAUDE report 12698911 ↗
• InjuryOct 17, 2021Adverse Event Without Identified Device or Use Problem; Material Separation; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS DISCOVERED UNCONSCIOUS AT HOME BY A FAMILY MEMBER AND WAS BROUGHT TO THE HOSPITAL WHERE AN IMAGING PROCEDURE WAS PERFORMED. IMAGING SHOWED THAT THE ANEURYSM SAC APPEARED TO BE ENLARGED AND COMPONENT SEPARATION. THE PATIENT HAS REFUSED FURTHER TREATMENT. REVIEW OF IMAGING SUPPLIED SHOWS A SEPARATION BETWEEN A ZFEN-D AND ZFEN-P GRAFTS.

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

  MAUDE report 12644453 ↗
• InjuryJun 24, 2019Material Deformation

  THE GRAFT IN-FOLDED ON ITSELF. IT DID NOT GET TO ITS FULL DIAMETER. IT WAS OVER-SIZED SO IT CRINKLED AND CREATED A TYPE ONE ENDOLEAK. IT INVAGINATED ON ITSELF. NO REINTERVENTION HAS BEEN PERFORMED YET. THE DOCTOR WILL BRING THE PATIENT BACK IN A FEW MONTHS TO SEE IF THE PROBLEM HAS RESOLVED ON ITS OWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8726387 ↗
• InjuryDec 2, 2018Adverse Event Without Identified Device or Use Problem

  POST-PROCEDURE, THE LEFT RENAL SHUTDOWN. DURING THE CASE, THE LEFT RENAL WAS DISSECTED. IT IS BELIEVED TO BE THE LIKELY CAUSE OF THE RENAL SHUTDOWN. NO SECONDARY INTERVENTION ON THE LEFT RENAL WAS PERFORMED AFTER IT SHUTDOWN.

  Patient problems: Renal Failure

  MAUDE report 8123191 ↗
• InjuryFeb 18, 2018Leak/Splash

  THE PROXIMAL AND DISTAL COMPONENTS LOST THEIR OVERLAP CREATING A TYPE 3 ENDOLEAK. THE PATIENT'S ANEURYSM RUPTURED AND PATIENT BECAME HYPOTENSIVE. THE PROXIMAL AND DISTAL COMPONENTS WERE REALIGNED WITH AN ADDITIONAL GRAFT. THE DISCONNECT JUNCTURE POINT WAS STRADDLED WITH THE JUNCTURE PIECE AND THE LEAK WAS SEALED. THE PATIENT REQUIRED BLOOD PERFUSION.

  Patient problems: Aneurysm; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 7279568 ↗
• MalfunctionJun 27, 2017Fracture; Difficult to Remove; Failure to Align

  UPON REMOVING THE SHIPPING PROTECTOR, IT WAS DIFFICULT TO REMOVE. AN ATTEMPT WAS MADE TO PULL OFF THE PROTECTOR WITH AN INSTRUMENT (EX. FORCEP). THE TWO ENDS WERE CUT AND THE PROTECTOR WAS PEELED AWAY FROM THE DEVICE. AS THE DEVICE WAS DIFFICULT TO REMOVE FROM ITS PROTECTOR, IT WAS VIEWED UNDER XRAY AND STRUTS LOOKED TO BE MISALIGNED. UPON UNSHEATHING FENESTRATED GRAFT ON BACK TABLE, STENT STRUT CONFIGURATION FOR A 10MM IN DIAMETER LARGE FENESTRATION WAS NOTICED TO BE IN AN ALTERNATIVE CONFIGURATION THAN WHAT WAS NOTED IN IMAGES THAT CAME WITH UNOPENED GRAFT. UPON CLOSER EXAMINATION, STRUT WAS FOUND TO BE COMPLETELY FRACTURED APART. CASE WAS CANCELED AS A RESULT OF CONCERN OF STRUCTURAL INTEGRITY AND PATIENT SAFETY. 09 AUGUST 17 UPDATE AFTER ADDITIONAL INFORMATION WAS RECEIVED ON THE 20 JULY 17: QUESTION: CAN YOU CONFIRM THAT DURING THE INSPECTION PRIOR TO USE, IF THERE WAS ANY EVIDENCE OF DAMAGE TO THE SHIPPING BOX AND DEVICE? DURING EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THERE WAS A BEND ON ONE SIDE OF THE SHIPPING BOX. ANSWER: NO, THERE WAS NOTHING WRONG WITH THE BOX. THE BEND IN THE SIDE OF THE BOX WAS FROM ME BENDING IT AFTER THE GRAFT WAS ALREADY OUT TO GET T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6672311 ↗
• DeathJun 19, 2017Insufficient Device Problem Information

  THE PATIENT HAD A FENESTRATED ENDOGRAFT PLACED ON (B)(6) 2017. THE PATIENT PRESENTED AT THE HOSPITAL ON (B)(6) 2017 WITH RUPTURED PSEUDOANEURYSM OFF OF THE LEFT RENAL ARTERY (8 DAYS POST OP). THE PHYSICIAN CALLED THE CLINICAL SPECIALIST TO REQUEST INFORMATION REGARDING THE INITIAL CASE, WHICH THE CLINICAL SPECIALIST STATED WAS A STANDARD CASE (COMPLETED SUCCESSFULLY). THE PHYSICIAN INFORMED THE CLINICAL SPECIALIST THAT THE LEFT RENAL ARTERY WAS EMBOLIZED IN AN ATTEMPT TO STOP THE BLEEDING FORM THE RUPTURED PSEUDOANEURYSM. THE PHYSICIAN REQUESTED ADDITIONAL INFORMATION REGARDING ANY POSSIBLE INTERVENTION IF IT WOULD BE NEEDED. THE PHYSICIAN STATED DURING THIS CALL THAT THE PATIENT SEEMED MORE STABLE THAN WHEN THEY PRESENTED WITH THE RUPTURED PSEUDOANEURYSM .THE CLINICAL SPECIALIST CHECKED ON THE PATIENT WITH THE FACILITY ON (B)(6) 2017 AND WAS INFORMED THE PATIENT HAD EXPIRED.

  Patient problems: Death

  MAUDE report 6652651 ↗
• MalfunctionMay 3, 2017Difficult to Remove

  THE TOP CAP TRIGGER WIRE MECHANISM TOOK SEVERE FORCE TO REMOVE. 19 MAY 2017 UPDATE : "A LOT OF FORCE AND ROTATION OF THE GREY POSITIONER AT THE SAME TIME WAS ULTIMATELY WHAT RELEASED THE TRIGGER WIRE. IT WAS A FENESTRATED CASE AND WE HAD TO ROTATE THE GRAFT TO ALIGN IT BEFORE DEPLOYING SO WHEN WE MET RESISTANCE THE SURGEON ROTATED THE GREY POSITIONER IN REVERSE AND THEN PULLED THE TRIGGER WIRES SIMULTANEOUSLY". "I UNFORTUNATELY DO NOT HAVE THE IMAGES ANYMORE SO CANNOT CONFIRM TORTUOSITY." "WE HAD TO ROTATE THE GRAFT SIGNIFICANTLY TO GET IT BACK ANTERIOR AFTER INSERTING IN TO THE AORTA."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6543023 ↗
• MalfunctionNov 27, 2016Mechanical Problem

  THE WHITE WIRE TRIGGER MECHANISM WOULD NOT RELEASE. THE PHYSICAN WAS ABLE TO COMPLETE THE PROCEDURE WITH THE COMPLAINT DEVICE SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6128206 ↗
• MalfunctionAug 16, 2016Premature Activation; Device Operates Differently Than Expected

  UPON REMOVING THE BLACK TRIGGER WIRE SAFETY FOR THE TOP CAP, IT DEPLOYED THE TOP CAP. THE PIN VICE WAS STILL TIGHTENED. THE CASE WAS ABLE TO BE COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5881039 ↗

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-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-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-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-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-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-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-3133-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-26-125-ZT, REF G48415, 18 Fr ID/ 7.1 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-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-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-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-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-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-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.

…and 96 more.