Zenith G32547Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002325477), received between Jul 25, 2016 and Jun 14, 2023 — classified as 2 deaths, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2023Defective Device; Material Twisted/Bent; Defective Device; Material Twisted/Bent

  WHILE ORIENTING THE DEVICE OUTSIDE OF PATIENT'S BODY UNDER FLUORO, IT WAS NOTED TO BE 'CANDY-WRAPPED' THE LRA FENESTRATION APPEARED TO BE PULLED AROUND AND SUPERIMPOSED UNDER THE RRA FENESTRATION. ALL OF THE STRUTS WERE TILTED AND TWISTED. THE USER DECIDED TO MOVE FORWARD AND ADVANCED THE DEVICE INTO THE PATIENT. THEY USED SEVERAL IMAGES AND ORIENTATION TECHNIQUES WHILE UNSHEATHING AND UNTWISTING - FINALLY GETTING IT ANTERIOR AND STRAIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17132115 ↗
• DeathMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH RENAL FAILURE AND ABDOMINAL PAIN WAS DECIDED NOT TO PURSUE DIALYSIS. THE PATIENT DIED SEVERAL DAYS LATER.

  Patient problems: Abdominal Pain; Renal Failure

  MAUDE report 14319931 ↗
• DeathApr 28, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH RENAL FAILURE AND ABDOMINAL PAIN WAS DECIDED NOT TO PURSUE DIALYSIS. THE PATIENT DIED SEVERAL DAYS LATER.

  Patient problems: Abdominal Pain; Renal Failure

  MAUDE report 14231741 ↗
• InjuryJun 9, 2019Positioning Problem

  THE DOCTOR REALIZED THAT AS HE WAS ADVANCING THE DEVICE IT ROTATED DUE TO THE ANATOMY AND WAS LANDED UPSIDE DOWN. THE GRAFT COVERED THE SUPERIOR MESENTERIC ARTERY (SMA) AND RIGHT RENAL. THE EVENT LED TO OPEN REMOVAL OF GRAFT AND OPEN REPAIR.

  Patient problems: No Code Available; Occlusion

  MAUDE report 8681368 ↗
• InjuryFeb 13, 2019Therapeutic or Diagnostic Output Failure

  THE ZFEN DEVICE WAS DEPLOYED OVER A .035 LES 260CM GUIDE WIRE PER STANDARD FASHION AT THE LEVEL OF THE PATIENT'S RENAL ARTERIES. A CATHETER WAS USED TO CUMULATE THE LEFT RENAL ARTERY OVER A 260 SOFT ANGLED GLIDE WIRE (TERUMO). THIS CATHETER WAS ADVANCED INTO THE LEFT RENAL AT WHICH TIME THE GLIDE WIRE WAS REMOVED AND A ROSEN 260 .035 GUIDE WIRE WAS EXCHANGED. THIS CATHETER THEN WAS PULLED OUT OF THE RENAL AND THEN A COOK 7FR X 55CM ANSEL 1 SHEATH WAS ADVANCED OVER THE ROSEN GUIDE WIRE WITH DILATOR AND INTO THE LEFT RENAL ARTERY. ONCE THE DILATOR WAS PULLED OUT OF THE SHEATH THE GORE BALLOON EXPANDABLE 6X29 VBX WAS ADVANCED INTO THE SHEATH AND PLACED JUST DISTAL TO THE TIP OF THE 7FR SHEATH WITHOUT BEING DEPLOYED. ONCE THESE SAME STEPS WERE REPEATED FOR THE RIGHT RENAL ARTERY THE ZFEN DEVICE WAS DEPLOYED PER STANDARD FASHION AND A CODA BALLOON WAS USED TO MAXIMIZE PROXIMAL SEAL. ONCE THIS BALLOONING WAS COMPLETE THE LEFT RENAL SHEATH WAS PULLED BACK INTO THE ZFEN DEVICE AND THE 6X29 GORE VBX IN QUESTION WAS INFLATED TO ITS NOMINAL DIAMETER. A OSTIAL FLASH OTW BALLOON SYSTEM 6MM X12 MM WAS USED TO SEAT THE VBX AND FLARE THE PROXIMAL EDGE OF THE STENT INSIDE THE ZFEN DEVICE.SO

  Patient problems: Renal Failure

  MAUDE report 8337590 ↗
• InjuryJul 25, 2016Leak/Splash

  AT 1188 DAYS POST-PROCEDURE, AN INTERVENTION WAS PERFORMED TO TREAT ANEURYSM GROWTH DUE TO WHAT WAS THOUGHT TO BE A TYPE II ENDOLEAK. DURING THE PROCEDURE THE ENDOLEAK WAS FOUND TO BE AT THE JUNCTION BETWEEN THE LEFT RENAL STENT AND LEFT RENAL FENESTRATION. ANGIOPLASTY WAS PERFORMED AND AN ICAST STENT WAS PLACED IN THE LEFT RENAL ARTERY. THE INTERVENTION WAS SUCCESSFUL. THE SITE REVISED ITS ASSESSMENT FROM A TYPE II ENDOLEAK TO A PROXIMAL TYPE I ENDOLEAK ON (B)(6) 2016.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5821247 ↗

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

…and 96 more.