Zenith G32534Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002325347), received between Sep 19, 2018 and Mar 21, 2022 — classified as 2 deaths, 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2022Difficult to Advance; Difficult to Advance

  DIFFICULTY WAS EXPERIENCED ADVANCING THE DEVICE INTO THE AORTA. THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO DILATE THE ILIACS. AN ATTEMPT TO ACCESS THE ILIAC LIMBS FROM THE OTHER SIDE WAS TRIED, BUT IT WAS DEEMED TO BE LESS FAVOURABLE. A CONSERVATIVE APPROACH WAS THEN TAKEN, AND THE DEVICE WAS REMOVED. FINALLY, A SELF-EXPANDING STENT WAS PLACED IN EACH ILIAC. TREATMENT OPTIONS WILL BE REVIEWED FOR FURTHER FOLLOW UP/PROCEDURES AT A LATER DATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13843340 ↗
• MalfunctionMar 8, 2022Failure to Advance; Output Problem; Failure to Advance

  DIFFICULTY WAS EXPERIENCED ADVANCING THE DEVICE INTO THE AORTA. THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO DILATE THE ILIACS. AN ATTEMPT TO ACCESS THE ILIAC LIMBS FROM THE OTHER SIDE WAS TRIED, BUT IT WAS DEEMED TO BE LESS FAVOURABLE. A CONSERVATIVE APPROACH WAS THEN TAKEN, AND THE DEVICE WAS REMOVED. FINALLY, A SELF-EXPANDING STENT WAS PLACED IN EACH ILIAC. TREATMENT OPTIONS WILL BE REVIEWED FOR FURTHER FOLLOW UP/PROCEDURES AT A LATER DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694045 ↗
• InjuryNov 18, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  NO PROBLEM WITH THE DEVICE WAS ALLEGED. ONE DAY AFTER PLACEMENT, THE PATIENT DEVELOPED BOWEL ISCHEMIA. THE PATIENT REQUIRED SURGERY FOR BOWEL (COLON) RESECTION AND COLOSTOMY. FURTHER INFORMATION PROVIDED, THE PATIENT EXPIRED A FEW DAYS AFTER THE PROCEDURE.

  Patient problems: Ischemia

  MAUDE report 12838514 ↗
• DeathNov 3, 2021Obstruction of Flow; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  NO PROBLEM WITH THE DEVICE WAS ALLEGED. ONE DAY AFTER PLACEMENT, THE PATIENT DEVELOPED BOWEL ISCHEMIA. THE PATIENT REQUIRED SURGERY FOR BOWEL (COLON) RESECTION AND COLOSTOMY. THE PATIENT EXPIRED A FEW DAYS AFTER THE PROCEDURE.

  Patient problems: Ischemia

  MAUDE report 12749910 ↗
• MalfunctionNov 13, 2018Leak/Splash; Activation, Positioning or Separation Problem

  THE ZFEN DEVICE WAS USED TO FIX A TYPE 1A ENDOLEAK OF A PREVIOUSLY PLACED DEVICE. THERE WAS AN ISSUE WITH THE ZFEN DEVICE. IT DEPLOYED FINE, BUT WHEN TRYING TO DOCK THE GREY POSITIONER AND TOP CAP, THE GREY POSITIONER WOULD NOT ADVANCE TO MEET THE TOP CAP. IT ALMOST LOOKED LIKE THE GREY POSITION GOT CAUGHT ON A SUTURE OR STENT/FABRIC OF THE FIRST COVERED SEAL STENT. SEVERAL TROUBLE SHOOTING TECHNIQUES WERE USED WITH NO SUCCESS. THE GREY POSITIONER WAS STUCK IN THE FIRST SEAL STENT. THE SURGEON HAD TO USE A LOT OF FORCE TO PULL THE GREY POSITIONER FREE. THE FIRST ENDOSTENT WAS NO LONGER ATTACHED TO THE FABRIC ABOVE THE LEFT RENAL. IT IS STILL ATTACHED ABOVE THE RIGHT RENAL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Known Impact Or Consequence To Patient

  MAUDE report 8066943 ↗
• DeathSep 19, 2018Insufficient Device Problem Information

  THE PHYSICIAN FELT THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

  Patient problems: Death; Ischemia

  MAUDE report 7891974 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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-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.

…and 96 more.