Zenith G32500Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002325002), received between Jul 17, 2020 and Jul 26, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2020Fluid/Blood Leak; Material Puncture/Hole; Material Split, Cut or Torn; Material Split, Cut or Torn

  FINAL ANGIO SHOWED AN ENDOLEAK DISTAL TO PROXIMAL & DISTAL BODY OVERLAP. DRS. USED A CODA BALLOON TO HELP SEAL PROXIMAL AND DISTAL BODY OVER LAP (ABOUT 3.5 STENT OVERLAP) & THEN DID ANOTHER ANGIO. THE LEAK WAS STILL THERE. DRS. INFLATED 32 CODA BALLOON IN OVERLAP OF THE PROXIMAL & DISTAL BODY AND PLACED A PIGTAIL MARKER JUST DISTAL TO THE OVERLAP (UP THE CONTRA SIDE - LEFT ILIAC) AND DID AN ANGIO TO SEE IF THERE WAS STILL A LEAK. THE ENDOLEAK WAS NOT COMING FROM THE PROXIMAL & DISTAL BODY OVERLAP, IT LOOKS LIKE IT IS COMING FROM A HOLE OR TEAR IN THE DISTAL PANTS, JUST PROXIMAL TO THE CONTRA LIMB OVERLAP. DRS. PLACED AN ESBE TO HELP SEAL ENDOLEAK. IT LOOKS LIKE A SMALL LEAK IS STILL THERE. DRS. PLAN TO RESCAN PATIENT IN THE NEXT 30 DAYS OR SO TO SEE IF THE LEAK HAS SEALED OFF.

  Patient problems: No Code Available

  MAUDE report 10324446 ↗
• InjuryJul 17, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  FINAL ANGIO SHOWED AN ENDOLEAK DISTAL TO PROXIMAL & DISTAL BODY OVERLAP. DRS. USED A CODA BALLOON TO HELP SEAL PROXIMAL AND DISTAL BODY OVER LAP (ABOUT 3.5 STENT OVERLAP) & THEN DID ANOTHER ANGIO. THE LEAK WAS STILL THERE. DRS. INFLATED 32 CODA BALLOON IN OVERLAP OF THE PROXIMAL & DISTAL BODY AND PLACED A PIGTAIL MARKER JUST DISTAL TO THE OVERLAP (UP THE CONTRA SIDE - LEFT ILIAC) AND DID AN ANGIO TO SEE IF THERE WAS STILL A LEAK. THE ENDOLEAK WAS NOT COMING FROM THE PROXIMAL & DISTAL BODY OVERLAP, IT LOOKS LIKE IT IS COMING FROM A HOLE OR TEAR IN THE DISTAL PANTS, JUST PROXIMAL TO THE CONTRA LIMB OVERLAP. DRS. PLACED AN ESBE TO HELP SEAL ENDOLEAK. IT LOOKS LIKE A SMALL LEAK IS STILL THERE. DRS. PLAN TO RESCAN PATIENT IN THE NEXT 30 DAYS OR SO TO SEE IF THE LEAK HAS SEALED OFF.

  Patient problems: No Code Available

  MAUDE report 10288193 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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-3143-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-73-ZT, REF G48462, 16Fr ID/ 6.0 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.

…and 96 more.