Zenith G32530Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002325309), received between Aug 19, 2018 and Aug 19, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Leak/Splash” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2018Leak/Splash; Material Deformation

  ON (B)(6) 2013, THE PATIENT RECEIVED A PROXIMAL COMPONENT, A DISTAL COMPONENT AND A SPIRAL Z ILIAC LEG. ONE 6 MM X 22 MM ATRIUM ICAST STENT WAS PLACED IN THE RIGHT RENAL ARTERY. ONE 6 X 22 MM ATRIUM ICAST STENT WAS PLACED IN THE LEFT RENAL ARTERY. THE IMPLANTING PHYSICIAN NOTED DIFFICULTY DEPLOYING THE FENESTRATION STENTS - THE LEFT RENAL FENESTRATION WAS NOT ALIGNED UPON DEPLOYMENT. AT THE CONCLUSION OF THE CASE, THE ENDOVASCULAR GRAFT AND BOTH FENESTRATED AND STENTED RENAL ARTERIES WERE PATENT. A PROXIMAL TYPE I ENDOLEAK WAS NOTED AT THE PROXIMAL LANDING ZONE BUT WAS NOT TREATED. A KINK WAS NOTED IN THE LEFT SPIRAL-Z LIMB. THE LIMB WAS REINFORCED WITH A 12 MM X 20 MM LIFESTAR STENT. THE PATIENT¿S ESTIMATED BLOOD LOSS WAS 800 CC AND THE PATIENT RECEIVED 1500 CC OF PACKED RED BLOOD CELLS (PRBCS) AND 250 CC OF FRESH FROZEN PLASMA (FFP) INTRA-OPERATIVELY. NO PATIENT-RELATED ADVERSE EVENTS WERE OBSERVED DURING THE PROCEDURE. CORE LAB REVIEW OF THE PROCEDURAL ANGIOGRAM REPORTED AN UNKNOWN TYPE ENDOLEAK. THREE STENT OVERLAP WAS NOTED BETWEEN THE PROXIMAL AND DISTAL GRAFTS. ONE STENT OVERLAP WAS NOTED BETWEEN THE DISTAL GRAFT AND THE LIMB COMPONENT. ON (B)(6) 2013, A POST-PROCEDURE CT SC

  Patient problems: Abdominal Pain; Anemia; Fall; Hemorrhage/Blood Loss/Bleeding; Rupture

  MAUDE report 7796260 ↗

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-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-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-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-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-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-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-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-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.
• 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-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-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-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.

…and 96 more.