Zenith G32536Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002325361), received between Aug 6, 2017 and Mar 15, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Coagulation in Device or Device Ingredient” (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.

• MalfunctionMar 15, 2026Material Twisted/Bent; Patient Device Interaction Problem

  AN 81-YEAR-OLD FEMALE PATIENT UNDERWENT A ZFEN FOR AAA PROCEDURE IN WHICH THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY, G32536, WAS USED. THE GRAFT WAS INSERTED INTO TORTUOUS ANATOMY AND WAS ROTATED (ROTATING THE GRAY POSITIONER AND SHEATH IN UNISON) TO CORRECT POSITION. THE GRAFT WAS UNSHEATHED AND CANDY-WRAPPING WAS NOTICED. THE GRAFT WAS THEN ROTATED IN THE OPPOSITE DIRECTION TO "UNWRAP". RENAL ARTERIES WERE CANNULATED AND ANSEL SHEATHS WERE ADVANCED INTO POSITION. WHEN THE GOLD TRIGGER WIRE WAS PULLED AND RELEASED, THE PHYSICIAN NOTICED SOME TENSION. THE BLACK TRIGGER WIRE WAS RELEASED AND PULLED WITH SOME TENSION AS WELL. THE PIN VISE WAS LOOSENED, THE TOP CAP WAS ADVANCED, AND THE PIN VISE TIGHTENED. THE WHITE TRIGGER WIRE WAS PULLED, AND THE WIRE BROKE OFF, FLUSH WITH THE TRIGGER MECHANISM. ADVANCED TROUBLE SHOOTING TECHNIQUES WERE FOLLOWED TO EXPOSE THE TRIGGER WIRE. THE TRIGGER WIRE WAS PULLED AND EXTREMELY TIGHT. EVENTUALLY, THE WIRE WAS REMOVED AND THE CASE WAS COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED: THE DEVICE WAS TWISTED DUE TO THE TORTUOUS ILIAC OF THE PATIENT. THERE WAS SOME EVIDENCE TO SUGGEST THE GRAFT MAY HAVE BEEN TWISTED PRIOR TO INSERTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24602063 ↗
• InjuryApr 2, 2019Coagulation in Device or Device Ingredient

  THE ORIGINAL IMPLANT ON (B)(6) 2019 WAS SUCCESSFUL. THE FOLLOW UP CT SHOWED NO ISSUES, ALL VESSELS WERE NOTED TO BE PATENT. THE PATIENT WAS RELEASED FROM HOSPITAL. 19 DAYS POST PROCEDURE, ON (B)(6) 2019 THE PATIENT PRESENTED WITH THROMBOSED LEFT RENAL AND SUPERIOR MESENTERIC ARTERY (SMA) STENTS. THE DOCTOR PERFORMED AN EMERGENT SUPERIOR MESENTERIC ARTERY (SMA) BYPASS.

  Patient problems: Occlusion

  MAUDE report 8475693 ↗
• InjuryAug 6, 2017Occlusion Within Device

  THE PATIENT'S FENESTRATED GRAFT PROCEDURE HAPPENED ON THE (B)(6) 2017. THE PATIENT RECEIVED THE DEVICE AND 2 ADDITIONAL I-CAST STENTS (NOT MANUFACTURED BY COOK MEDICAL). IN THE MIDDLE OF THE AFTERNOON ON (B)(6) 2017 THE PATIENT STARTED COMPLAINING OF BACK PAIN AND HAD NO URINE PRODUCTION (ANURIC). THE PATIENT WAS TAKEN TO THE OPERATING ROOM IN THE AFTERNOON OF (B)(6) FOR AN ANGIOGRAM. THE DOCTOR DID ANGIOS OF THE ABDOMINAL AORTA AND SELECTIVE ANGIOS OF EACH RENAL ARTERY. BOTH RENAL ARTERIES WERE FOUND TO BE OCCLUDED AT THE DISTAL END OF THE RENAL I-CAST STENTS. THROMBECTOMY & PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED TO RESTORE BLOOD FLOW IN THE RENAL ARTERIES.

  Patient problems: Occlusion; Pain; Urinary Retention

  MAUDE report 6769841 ↗

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

…and 96 more.