Zenith G32549Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002325491), received between Apr 15, 2020 and Jun 27, 2022 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2022Migration; Migration

  THE GRAFT SYSTEM WAS IMPLANTED APPROXIMATELY THREE YEARS AGO. RECENTLY, THE BIFURCATED GRAFT SEPARATED FROM THE TUBE GRAFT AND CAME OUT OF TUBE GRAFT. THE PHYSICIAN HAD TO RELINE THE ENDOGRAFT AND WAS ABLE TO FIX THE GRAFT SYSTEM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14830034 ↗
• InjuryJun 20, 2022Device Slipped; Migration; Device Slipped; Separation Failure; Migration

  THE GRAFT SYSTEM WAS IMPLANTED APPROXIMATELY THREE YEARS AGO. RECENTLY, THE BIFURCATED GRAFT SEPARATED FROM THE TUBE GRAFT AND CAME OUT OF TUBE GRAFT. THE PHYSICIAN HAD TO RELINE THE ENDOGRAFT AND WAS ABLE TO FIX THE GRAFT SYSTEM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14750510 ↗
• InjuryFeb 23, 2021Difficult or Delayed Positioning; Difficult or Delayed Positioning; Positioning Problem; Activation Problem

  THE ANTERIOR MARKERS WERE NOT RESPONDING TO THE ROTATION. HOWEVER, THE POSTERIOR MARKERS WERE RESPONDING TO THE ROTATION. THIS IS DONE FOR VERIFICATION PURPOSES BEFORE IMPLANT VIA X-RAY. AT THIS POINT, THE PHYSICIAN WAS CONTEMPLATING NOT TO IMPLANT; BUT DECIDED TO PROCEED WITH THE CASE. THE DEVICE WAS IMPLANTED. STARTED TO DEPLOY AFTER CONFIRMING ORIENTATION AND THERE WAS DIFFICULTY ROTATING THE DEVICE AFTER THE FIRST TWO STENTS WERE DEPLOYED. THE PHYSICIAN STRUGGLED TO MANEUVER AND ADJUNCT PROCEDURES WERE CONDUCTED TO HELP THE DEVICE ROTATE. THE PHYSICIAN WAS ABLE TO STENT THE LEFT RENAL, BUT WERE UNABLE TO STENT THE RIGHT RENAL FENESTRATION. THE RIGHT KIDNEY WAS STILL PROFUSING, BUT THE RIGHT RENAL ARTERY WAS NOT STENTED. THE PHYSICIANS DECIDED TO STOP AND WAIT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11369218 ↗
• MalfunctionOct 27, 2020Material Twisted/Bent; Use of Device Problem; Material Twisted/Bent

  THE GRAFT WAS TWISTED ALL AROUND INSIDE THE CATHETER. ONE OF THE SMALL FENESTRATIONS WOULD NOT OPEN UP WHEN FLOWERED OUT/UNSHEATHING. THE GRAFT BELOW THE TAPER ALSO DID NOT OPEN UNTIL AFTER THE SURGEON ROTATED THE GRAFT ALMOST TWO FULL TURNS. THE GRAFT WAS NOT ROTATED AT ALL UPON INSERTION. THE SURGEON DID NOT CAUSE THE TWISTING. THE DEVICE WAS EVENTUALLY OPENED UP AS THE END RESULT AND SUCCESSFULLY COMPLETED THE PROCEDURE. THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10744260 ↗
• InjuryApr 19, 2020Separation Problem; Separation Problem

  THE PROXIMAL GRAFT SEPARATED FROM THE DISTAL GRAFT. THEY ARE SCHEDULED FOR A ESBE OR TX2 DISSECTION STENT TO BRIDGE THE GAP. INTERVENTION PROCEDURE IS SCHEDULED TO TAKE PLACE 'NEXT WEEK' (DATE OF THIS INFORMATION WAS THURSDAY (B)(6) 2020).

  Patient problems: No Code Available

  MAUDE report 9975869 ↗
• InjuryApr 15, 2020Separation Problem; Separation Problem

  AS STATED BY THE INITIAL REPORTER "THE TWO GRAFTS SEPARATED FROM ONE ANOTHER." THEY ARE SCHEDULED FOR A ESBE OR TX2 DISSECTION STENT TO BRIDGE THE GAP (INTERVENTION PROCEDURE IS SCHEDULED TO TAKE PLACE 'NEXT WEEK'.

  Patient problems: No Code Available

  MAUDE report 9963818 ↗

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-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-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-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-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-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-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-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-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-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-3138-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-36-95-ZT, REF G48432, 22 Fr ID/ 8.5 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-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.

…and 96 more.