Zenith G32532Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10827002325323), received between Mar 8, 2022 and May 29, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2024Material Twisted/Bent; Material Twisted/Bent

  THE ANTERIOR/POSTERIOR MARKERS ON THE PROXIMAL BODY OF THE FENESTRATED DEVICE DID NOT LOOK AS THOUGH THEY WERE POSITIONED CORRECTLY IN ORDER TO PROPERLY DEPLOY THE DEVICE. THIS REQUIRED THE USER TO RELY ON THE POSITION OF THE FENESTRATIONS ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19412988 ↗
• InjuryMay 21, 2024Material Twisted/Bent; Material Twisted/Bent

  THE 3:00 AND 10:15 RENALS WERE SUPERIMPOSED. 3 VERTICAL ANTERIOR MARKERS WERE BARELY ROTATED OFF THE CORE AND DIDN'T MOVE ENOUGH TO AID IN ORIENTATION. THE GRAFT WAS OPENED TO SEE WHAT WAS HAPPENING AND IT WAS OBSERVED THAT IT WAS RE-SHEATHED/CONSTRAINED IN A WAY THAT IT WAS INFOLDED INWARDS. THIS PUSHED RENALS TOGETHER AND SMASHED 3 VERTICAL ANTERIOR MARKERS AGAINST THE CORE, NOT ALLOWING THEM TO ROTATE. ONCE THE GRAFT WAS DEPLOYED, IT WAS NOT ALIGNED, AND COULD NOT BE ROTATED TO CORRECT IT. LATER IN THE CASE THE GRAY POSITIONER COULD NOT BE DOCKED WITH THE NOSE CONE WHICH ACCORDIONED THE SHEATH. THE ILIAC WAS CUT DOWN TO REMOVE THE DELIVERY SYSTEM. UPON OBSERVATION, THE GRAY POSITIONER WAS CUT/SHEARED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359879 ↗
• InjuryMay 1, 2024Material Twisted/Bent; Material Twisted/Bent

  THE 3:00 AND 10:15 RENALS WERE SUPERIMPOSED. 3 VERTICAL ANTERIOR MARKERS WERE BARELY ROTATED OFF THE CORE AND DIDN'T MOVE ENOUGH TO AID IN ORIENTATION. THE GRAFT WAS OPENED TO SEE WHAT WAS HAPPENING AND IT WAS OBSERVED THAT IT WAS RE-SHEATHED/CONSTRAINED IN A WAY THAT IT WAS INFOLDED INWARDS. THIS PUSHED RENALS TOGETHER AND SMASHED 3 VERTICAL ANTERIOR MARKERS AGAINST THE CORE, NOT ALLOWING THEM TO ROTATE. ONCE THE GRAFT WAS DEPLOYED, IT WAS NOT ALIGNED, AND COULD NOT BE ROTATED TO CORRECT IT. LATER IN THE CASE THE GRAY POSITIONER COULD NOT BE DOCKED WITH THE NOSE CONE WHICH ACCORDIONED THE SHEATH. THE ILIAC WAS CUT DOWN TO REMOVE THE DELIVERY SYSTEM. UPON OBSERVATION, THE GRAY POSITIONER WAS CUT/SHEARED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19227076 ↗
• InjuryDec 12, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  PER REP - THE PATIENT WAS SYMPTOMATIC. SO, THEY TOOK HIM FOR AN ANGIOGRAM. THE ANGIOGRAM REVEALED THAT THE RIGHT RENAL ARTERY WAS OCCLUDED. THE PHYSICIAN SAID THAT THE RIGHT RENAL ARTERY STENT APPEARED CRUSHED. THE CRUSHED STENT WAS A LIFESTREAM VASCULAR COVERED STENT MANUFACTURED BY BARD. THERE DID NOT APPEAR TO BE ANY PROBLEM WITH THE COOK COMPONENTS BUT THE PHYSICIAN WANTED THE REP TO REPORT THIS TO COOK ANYWAY. AFTER THE ANGIOGRAM, THE PHYSICIAN ATTEMPTED TO WIRE THE STENT AND THE RENAL ARTERY. AFTER THREE HOURS, HE WAS UNABLE TO GET INTO THE RENAL ARTERY. NO FURTHER ADDITIONAL PROCEDURES HAVE BEN PLANNED AT THIS TIME.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18312392 ↗
• InjuryNov 19, 2023Obstruction of Flow; Obstruction of Flow

  THE PATIENT WAS SYMPTOMATIC AND THEY PERFORMED AN ANGIOGRAM. THE ANGIOGRAM REVEALED THAT THE RIGHT RENAL ARTERY WAS OCCLUDED. THE PHYSICIAN SAID THAT THE RIGHT RENAL ARTERY STENT APPEARED CRUSHED. THE CRUSHED STENT WAS A LIFESTREAM VASCULAR COVERED STENT MANUFACTURED BY BARD. THERE DID NOT APPEAR TO BE ANY PROBLEM WITH THE COOK DEVICE. HOWEVER, IT IS NOT KNOWN IF THE COOK DEVICE MAY HAVE CONTRIBUTED TO THE DAMAGE NOTED. AFTER THE ANGIOGRAM, THE PHYSICIAN ATTEMPTED TO WIRE THE STENT AND THE RENAL ARTERY. AFTER THREE HOURS, HE WAS UNABLE TO GET INTO THE RENAL ARTERY. NO FURTHER ADDITIONAL PROCEDURES HAVE BEN PLANNED AT THIS TIME.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18167334 ↗
• InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT EXPERIENCED AN EMBOLIC EVENT AND WOKE UP PARALYZED, ONE DAY POST TREATMENT WITH A FENESTRATED DEVICE.

  Patient problems: Paralysis

  MAUDE report 13951784 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT EXPERIENCED AN EMBOLIC EVENT AND WOKE UP PARALYZED, ONE DAY POST TREATMENT WITH A FENESTRATED DEVICE.

  Patient problems: Paralysis; Paraplegia

  MAUDE report 13694072 ↗

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

…and 96 more.