Zenith G32548Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002325484), received between Apr 29, 2020 and Aug 26, 2020 — classified as 2 deaths, 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathAug 26, 2020Material Rupture; Material Rupture

  ACCORDING TO THE INITIAL REPORTER: "FENESTRATED SYSTEMS ARE SUPPOSED TO OVERLAP. THE DEVICE CAME DISCONNECTED OVER THE PAST FEW YEARS, PATIENT DIED IN APRIL. ONE DEVICE MIGRATED, NOT CONFIRMED BUT INITIAL REPORTER SPECULATES THAT DISTAL PIECE IS MORE LIKELY TO HAVE MIGRATED. CUSTOMER ALLEGING THAT DISCONNECTING WAS A CONTRIBUTING FACTOR. PATIENT PRESENTED TO ER WITH BELLY PAIN AT (MEDICAL FACILITY), CT SCAN PERFORMED THAT OBSERVED A RUPTURE, PATIENT WAS TRANSPORTED TO (MEDICAL FACILITY), FACILITY TRIED TO REPAIR DISCONNECTION, AND PATIENT DIED FROM COMPLICATIONS SUBSEQUENT TO THE ATTEMPT TO REPAIR. SUBSEQUENT TO REPAIR, PATIENT DEVELOPED COMPARTMENT SYNDROME AND PATIENT'S FAMILY DECLINED TO HAVE PATIENT GO BACK TO SURGERY." IT WAS REPORTED THAT THE PATIENT EXPIRED.

  Patient problems: Death

  MAUDE report 10453209 ↗
• DeathAug 25, 2020Device Slipped; Detachment of Device or Device Component; Migration; Device Slipped

  ACCORDING TO THE INITIAL REPORTER: "FENESTRATED SYSTEMS ARE SUPPOSED TO OVERLAP. THE DEVICE CAME DISCONNECTED OVER THE PAST FEW YEARS, PATIENT DIED IN APRIL. ONE DEVICE MIGRATED, NOT CONFIRMED BUT INITIAL REPORTER SPECULATES THAT DISTAL PIECE IS MORE LIKELY TO HAVE MIGRATED. CUSTOMER ALLEGING THAT DISCONNECTING WAS A CONTRIBUTING FACTOR. PATIENT PRESENTED TO ER WITH BELLY PAIN AT (MEDICAL FACILITY), CT SCAN PERFORMED THAT OBSERVED A RUPTURE, PATIENT WAS TRANSPORTED TO (MEDICAL FACILITY), FACILITY TRIED TO REPAIR DISCONNECTION, AND PATIENT DIED FROM COMPLICATIONS SUBSEQUENT TO THE ATTEMPT TO REPAIR. SUBSEQUENT TO REPAIR, PATIENT DEVELOPED COMPARTMENT SYNDROME AND PATIENT'S FAMILY DECLINED TO HAVE PATIENT GO BACK TO SURGERY." IT WAS REPORTED THAT THE PATIENT EXPIRED.

  Patient problems: Death

  MAUDE report 10449963 ↗
• InjuryMay 5, 2020Improper Flow or Infusion; Improper Flow or Infusion

  ZFEN WAS INVOLVED IN PROCEDURE, BUT PHYSICIAN BELIEVES ICAST WAS ALLEGEDLY THE PROBLEM DEVICE (LIMITED BLOOD FLOW INTO THE PATIENT'S RIGHT RENAL). IT WAS FURTHER REPORTED: AN ICAST WAS USED ON RT RENAL. 5X22X120. OTHER DEVICES USED DURING THE PROCEDURE: COOK DISTAL BODY 12-28-76 , ZSLE RT ILIAC, ZSLE LEFT ILIAC AND ICAST IN LEFT RENAL 6X22X120. THIS WAS A FENESTRATED CASE.

  Patient problems: Vascular System (Circulation), Impaired

  MAUDE report 10023211 ↗
• InjuryApr 29, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE INITIAL REPORTER:: "ZFEN WAS INVOLVED IN PROCEDURE, BUT PHYSICIAN BELIEVES ICAST WAS ALLEGEDLY THE PROBLEM DEVICE (LIMITED BLOOD FLOW INTO THE PATIENT'S RIGHT RENAL). " IT WAS FURTHER REPORTED: AN ICAST WAS USED ON RT RENAL. 5X22X120. OTHER DEVICES USED DURING THE PROCEDURE: COOK DISTAL BODY 12-28-76 , ZSLE RT ILIAC, ZSLE. LEFT ILIAC AND ICAST IN LEFT RENAL 6X22X120. THIS WAS A FENESTRATED CASE.

  Patient problems: Vascular System (Circulation), Impaired

  MAUDE report 10009535 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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

…and 96 more.