Zenith G32546Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002325460), received between Sep 16, 2018 and Oct 1, 2019 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 1, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  FOLLOWING THE PROCEDURE FOR IMPLANTATION, THERE WAS A LEAK AT THE DISTAL EDGE OF THE OVERLAP BETWEEN THE TWO DEVICES ON COMPLETION ANGIOGRAM. THE SOURCE OF THE LEAK COULD NOT BE DETERMINED. THE PHYSICIAN IMPLANTED TWO ADDITIONAL COVERED STENTS EXTENDING SLIGHTLY ABOVE THE FLOW DIVIDER AND POST DILATED THEM. ANOTHER ANGIOGRAM FOLLOWING THIS SHOWED THE LEAK TO BE REPAIRED BUT THE EXACT SOURCE OF THE LEAK WAS NOT IDENTIFIED.

  Patient problems: No Code Available

  MAUDE report 9141851 ↗
• InjurySep 17, 2019Leak/Splash

  FOLLOWING THE PROCEDURE FOR IMPLANTATION, THERE WAS A LEAK AT THE DISTAL EDGE OF THE OVERLAP BETWEEN THE TWO DEVICES ON COMPLETION ANGIOGRAM. THE SOURCE OF THE LEAK COULD NOT BE DETERMINED. THE PHYSICIAN IMPLANTED TWO ADDITIONAL COVERED STENTS EXTENDING SLIGHTLY ABOVE THE FLOW DIVIDER AND POST DILATED THEM. ANOTHER ANGIOGRAM FOLLOWING THIS SHOWED THE LEAK TO BE REPAIRED BUT THE EXACT SOURCE OF THE LEAK WAS NOT IDENTIFIED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9079571 ↗
• MalfunctionSep 15, 2019Difficult or Delayed Activation

  GRAFT DEPLOYED. CANNULATION OF RENAL ARTERIES DONE. ALL 3 TRIGGER WIRES PULLED. TOP CAP DEPLOYED. WHEN TRYING TO GO AND RECAPTURE THE TOP CAP, THE GRAY POSITIONER WAS VERY DIFFICULT TO PUSH UP THRU THE GRAFT. WITH A LOT OF FORCE, THE PHYSICIAN WAS ABLE TO GET THE GRAY POSITIONER UP TO THE TOP CAP. THE REST OF THE PROCEDURE WENT AS PLANNED. NO ENDOLEAK SEEN ON FINAL ANGIO. A FOLLOW UP POST CT WITH NO CONTRAST THE FOLLOWING DAY TO CHECK THE INTEGRITY OF THE GRAFT, AND THE PHYSICIAN COMMENTED ONE OR TWO OF THE Z-STENTS LOOKED "UNUSUAL" ON THE CT. THE PATIENT WAS DISCHARGED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9067714 ↗
• MalfunctionNov 6, 2018Break; Difficult to Remove; Positioning Problem

  THE TORTUOSITY OF ILIACS AND AORTA WAS EXTREME. THE ROTATION OF THE UNSHEATHED DEVICE WAS VERY DIFFICULT. IT REQUIRED OVER ROTATION OF APPROXIMATELY 7- 8 X 360 DEGREE ROTATIONS TO MOVE THE GRAFT 15 MIN. AFTER CANNULATION OF THE SUPERIOR MESENTERIC ARTERY (SMA) AND INABILITY TO CANNULATE RENALS, THE PHYSICIAN DECIDED TO RELEASE ALL TRIGGER WIRES AND REMOVE DELIVERY SYSTEM. THE PHYSICIAN UNWOUNDED THE SYSTEM APPROXIMATELY 6 X 360 ROTATIONS, UNTIL THE SMA FENESTRATION RISKED GOING OUT OF POSITION. THE CONSTRAINT TRIGGER WIRE WAS DIFFICULT, THE TOP CAP WIRE WAS NOT BUDGING, IT BROKE AT THE THUMB SCREW HOUSING. FINALLY THE PHYSICIAN WAS ABLE TO REMOVE WITH A HEAVY CLAMP. THEN THE TOP CAP WOULD NOT PUSH OFF, IMPOSSIBLE TO MOVE AT ALL. THE PHYSICIAN PLACED A CODA BALLOON IN THE DISTAL END OF THE GRAFT AND WITH MUCH DIFFICULTY WAS ABLE TO PUSH THE CANULA NORTH WITH THE HEAVY CLAMP. THE DISTAL TRIGGER WIRE WAS DIFFICULT BUT DID PULL OUT. THE GREY PUSHER WOULD NOT TRACK NORTH AT ALL, BUT THE TOP CAP CAME DOWN WITH OUT GETTING HUNG UP. THE REST OF THE CASE PROGRESSED TO COMPLETION. IT WAS NOTED THAT THE PATIENT WAS EXPOSED TO LONGER FLUOROSCOPY TIME.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8044828 ↗
• InjurySep 16, 2018Obstruction of Flow

  THE PATIENT HAD A PREVIOUSLY PLACED ABDOMINAL AORTIC ANEURYSM DEVICE FROM 2007 AND HIS ANEURYSM CONTINUED TO GROW. THAT IS WHY THE FENESTRATED PIECE WAS PLACED. THE GRAFT PLACEMENT WENT FINE AND PLACED BOTH STENTS INTO RENAL ARTERIES. THE POST RENAL STENTING SHOWED FLOW TO BOTH RENAL ARTERIES. THE ILIAC LEGS WERE EXTENDED AND THEY SHOT A FINAL ANGIO; HOWEVER, THE LEFT RENAL DID NOT SHOW UP. MULTIPLE ATTEMPTS TO CANNULATE WERE MADE WITHOUT SUCCESS AND THE PROCEDURE WAS ABANDONED. THE PHYSICIAN DOES NOT KNOW IF THE STENT OCCLUDED BUT KNEW THE PROCEDURE WOULD BE RISKY AND HAD THE POTENTIAL TO LOSE THE LEFT RENAL BECAUSE OF STENTING THROUGH A PREVIOUSLY PLACED GRAFT. PATIENTS LEFT RENAL IS OCCLUDED AND LEFT KIDNEY IS GONE. THE RIGHT KIDNEY IS FUNCTIONING FINE AND THE FACILITY WILL MONITOR THE PATIENT. THEY WILL DO A CT ON THE PATIENT TO SEE WHAT MAY HAVE HAPPENED.

  Patient problems: Aneurysm; Renal Failure

  MAUDE report 7879745 ↗

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

…and 96 more.