Zenith G32541Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002325415), received between Aug 14, 2022 and Aug 25, 2022 — classified as 2 deaths.

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

• DeathAug 25, 2022Break; Break

  THE DEVICE WOULD ROTATE 180 DEGREES EVERY TIME IT WAS ADVANCED THROUGH THE GROIN. ROTATION WAS EVENTUALLY CORRECTED AND GRAFT DEPLOYMENT WAS BEGUN. AFTER OPENING THE FIRST TWO STENTS, THE ORIENTATION ROTATED ON THE GRAFT. ROTATION OF THE ENTIRE SYSTEM WAS PERFORMED. WHEN THE GRAFT WAS NOW CORRECTLY ORIENTED, THE DISTAL END OF THE GRAFT WAS OPENED. UPON, OPENING THE DISTAL END, IT WAS NOTED THAT THE GRAFT WAS WRAPPED AROUND ITSELF (LIKE A CANDY WRAPPER). CANNULATION OF THE FENESTRATIONS WAS PERFORMED FOR THE ARM THROUGH THE SCALLOP AS THE PHYSICIAN COULD NOT CANNULATE THROUGH THE WRAPPED GRAFT (FROM BELOW). THEREFORE, CANNULATION WAS DONE THROUGH THE ARM. UPON REMOVING, THE GOLD TRIGGER WIRE, THE WIRE SNAPPED. HEMOSTATS WERE THEN USED TO GRAB THE REMAINDER OF THE WIRE THAT SNAPPED FROM THE GOLD KNOB. THE BLACK TRIGGER WIRE ALSO SNAPPED AT THE HUB AND WAS UNABLE TO BE PULLED FROM THE DEVICE. THEREFORE, THE TOP CAP COULD NOT BE DEPLOYED. THE OPERATION WAS CONVERTED TO AN OPEN PROCEDURE. THE PATIENT EXPIRED IN THE ICU WHILE AT THE HOSPITAL. NOTE: THE PATIENT HAD AN EXISTING ENDOLOGICS GRAFT SITTING APPROX. 2 CM'S BELOW THE PATIENTS RENALS.

  Patient problems: Failure of Implant

  MAUDE report 15294596 ↗
• DeathAug 14, 2022Break; Entrapment of Device; Material Twisted/Bent; Activation Problem; Material Twisted/Bent

  THE DEVICE WOULD ROTATE 180 DEGREES EVERY TIME IT WAS ADVANCED THROUGH THE GROIN. ROTATION WAS EVENTUALLY CORRECTED AND GRAFT DEPLOYMENT WAS BEGUN. AFTER OPENING THE FIRST TWO STENTS, THE ORIENTATION ROTATED ON THE GRAFT. ROTATION OF THE ENTIRE SYSTEM WAS PERFORMED. WHEN THE GRAFT WAS NOW CORRECTLY ORIENTED, THE DISTAL END OF THE GRAFT WAS OPENED. UPON, OPENING THE DISTAL END, IT WAS NOTED THAT THE GRAFT WAS WRAPPED AROUND ITSELF (LIKE A CANDY WRAPPER). CANNULATION OF THE FENESTRATIONS WAS PERFORMED FOR THE ARM THROUGH THE SCALLOP AS THE PHYSICIAN COULD NOT CANNULATE THROUGH THE WRAPPED GRAFT (FROM BELOW). THEREFORE, CANNULATION WAS DONE THROUGH THE ARM. UPON REMOVING, THE GOLD TRIGGER WIRE, THE WIRE SNAPPED. HEMOSTATS WERE THEN USED TO GRAB THE REMAINDER OF THE WIRE THAT SNAPPED FROM THE GOLD KNOB. THE BLACK TRIGGER WIRE ALSO SNAPPED AT THE HUB AND WAS UNABLE TO BE PULLED FROM THE DEVICE. THEREFORE, THE TOP CAP COULD NOT BE DEPLOYED. THE OPERATION WAS CONVERTED TO AN OPEN PROCEDURE. THE PATIENT EXPIRED IN THE ICU WHILE AT THE HOSPITAL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 15223055 ↗

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

…and 96 more.