Zenith G32545Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002325453), received between Feb 5, 2017 and Nov 19, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2025Material Separation; Material Separation

  ACCORDING TO THE INITIAL REPORTER, THE REP SPOKE WITH THE PHYSICIAN ABOUT A FENESTRATED CASE PERFORMED ON (B)(6) 2025. THERE WAS A LEAK AT THE END OF THE CASE THAT COULDN¿T BE IDENTIFIED WHERE IT WAS COMING FROM. THE PHYSICIAN DECIDED TO DO A FOLLOW-UP CTA IN A WEEK TO DETERMINE IF THE LEAK IS STILL PRESENT AND TO SEE WHERE IT MIGHT BE COMING FROM. THE PHYSICIAN SHARED WITH THAT HE WANTED TO MAKE SURE THAT IT IS NOT COMING FROM A TEAR IN THE GRAFT FABRIC. AS OF NOW, THERE IS NO PATIENT HARM BUT WANTED TO MAKE AWARE THAT WE HAVE A FOLLOW-UP CTA IN A WEEK TO DETERMINE IF LEAK IS STILL PRESENT AND IF SO TO HELP IDENTIFY FROM WHERE IT MIGHT BE COMING FROM. THE IMPLANTED GRAFTS WERE AS FOLLOWS: G32545 ¿ LOT AC1192922. G32551 ¿ LOT AC1156059. G55243 ¿ LOT 15819493. G55245 ¿ LOT 16707596. G55207 ¿ LOT 16449683. PATIENT OUTCOME AS OF NOW ((B)(6) 2025), THERE IS NO PATIENT HARM BUT THE PHYSICIAN WANTED TO MAKE AWARE THAT WE HAVE A FOLLOW-UP CTA IN A WEEK TO DETERMINE IF LEAK IS STILL PRESENT AND IF SO TO HELP IDENTIFY FROM WHERE IT MIGHT BE COMING FROM. ADDITIONAL INFORMATION PROVIDED: NO DIFFICULTY DURING DEPLOYMENT. THERE WAS MINIMAL TORTUOSITY. THE GRAFTS WENT UP EASILY AND ALIGNED PERFE

  Patient problems: Clinical Endoleak

  MAUDE report 23593965 ↗
• MalfunctionJun 14, 2025Material Twisted/Bent; Material Twisted/Bent

  ANTERIOR/POSTERIOR MARKERS WERE NOT APPROPRIATELY ALIGNED, ENDED UP DEPLOYING THE GRAFT MORE THAN 30 DEGREES OFF: THE DEVICE WAS INSPECTED PRIOR TO USE IN ORDER TO ENSURE NO DAMAGE HAD OCCURRED. THE PROBLEM WAS IDENTIFIED WHEN PLACING THE GRAFT ON THE PATIENT'S ABDOMEN PRIOR TO INSERTION: THE ANTERIOR/POSTERIOR MARKERS WERE NOT APPROPRIATELY ALIGNED WITHIN THE GRAFT. THE MARKERS WERE OFF; CAUSING THE GRAFT ORIENTATION DURING UNSHEATHING TO BE OFF. THE MARKERS, WHEN FORMING THE CROSS, ENDED UP DEPLOYING THE GRAFT MORE THAN 30 DEGREES OFF. THIS WAS REMEDIED BY FOCUSING ON WHERE FENESTRATION ALIGNMENT SHOULD BE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE IN QUESTION. NO INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22208510 ↗
• MalfunctionFeb 5, 2017Device Markings/Labelling Problem; Incorrect Device Or Component Shipped

  THE GRAFT LAYOUT SPECIFIED THAT THE SCALLOP WAS 8 MM DEEP. DEVICE ORDER FORM WAS ORDERED AS A 12 MM DEEP SCALLOP. DUE TO THIS, THE PHYSICIAN HAD TO DEPLOY THE GRAFT ON THE BACK TABLE TO CONFIRM THE MEASUREMENT PRIOR TO IMPLANT. THE GRAFT WAS BUILT WITH A 12 MM SCALLOP AND THIS MEASUREMENT WAS CONFIRMED BY THE PHYSICIAN; HOWEVER THE PAPERWORK WAS INCORRECT AS IT INDICATED A 8 MM SCALLOP.

  Patient problems: No Information

  MAUDE report 6303089 ↗

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-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-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-3152-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-73-ZT, REF G48476, 16Fr ID/ 6.0 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-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-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-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-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-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-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-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-3154-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-24-73-ZT, REF G48478, 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-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-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

…and 96 more.