Zenith G32540Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002325408), received between Jan 21, 2018 and Jan 21, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Positioning Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2018Positioning Problem

  THE PROXIMAL COMPONENT GRAFT WAS ORIENTED ON TOP OF THE PATIENT¿S ABDOMEN PER IFU. THE GRAFT WAS THEN INTRODUCED INTO THE PATIENT VIA THE LEFT COMMON FEMORAL (LCF) ARTERY. AN ANGIOGRAM WAS DONE TO CONFIRM POSITION OF THE SUPERIOR MESENTERIC ARTERY (SMA) AND BOTH RENAL ARTERIES. DEVICE WAS POSITIONED WITH THE GUIDANCE OF OUR ANGIO. ONCE IN POSITION, THE DOCTOR UNSHEATHED THE ENTIRE PROXIMAL COMPONENT. HE THEN CANNULATED THE BOTTOM OF THE GRAFT. ONCE INSIDE THE GRAFT THROUGH THE 20F SHEATH IN THE RIGHT COMMON FEMORAL (RCF) ARTERY, THE LEFT RENAL ARTERY (LRA) WAS CANNULATED AND A 7F ANSEL SHEATH WAS ADVANCED INTO THE LRA. THE DOCTOR THEN ATTEMPTED TO CANNULATE THE RIGHT RENAL ARTERY (RRA). THE DOCTOR WAS HAVING TROUBLE TELLING EXACTLY WHERE THE RRA OSTIUM WAS LOCATED. AFTER NUMEROUS ATTEMPTS WITH DIFFERENT CATHETERS, WIRES, ETC. THE DOCTOR DECIDED TO ADDRESS THE LRA & SMA AND THEN COME BACK TO THE RRA. THE SMA WAS CANNULATE WITHIN THE GRAFT AND A 7F 70CM ANSEL WAS ADVANCED TO THE FENESTRATION. THE DOCTOR WAS UNABLE TO ADVANCE THE 7F SHEATH INTO THE SMA FENESTRATION. THE DOCTOR THEN WENT TO ADDRESS THE LRA. THE WIRE IN THE LRA WAS ACCIDENTALLY PULLED OUT BY THE SCRUB NURSE AND THE DOCT

  Patient problems: No Code Available

  MAUDE report 7208823 ↗

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

…and 96 more.