COOK G60345Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002603455), received between Jun 1, 2026 and Aug 25, 2026 — classified as 2 injuries.

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

• InjuryAug 25, 2026Fluid/Blood Leak

  The implant procedure was an iliac branch with a ZBIS on the left, with competitor grafts for everything else: EVAR hypo stent with VBX, gore limbs to bridge. They sealed into the top of the ZBIS with the 14.5 ispi leg of the exculder. Brisk endoleak was visible at level of the ZBIS flow divider. They then relined the VBX thinking maybe it was a type c and occuleded above the flow divider with a CODA. the leak was still there. They then relined the ipsi limb with another limb. Leak was still there. Reballooned and took different angles to rule out type 2 or any other leak elsewhere. Doctor seems confident now after reflection it could only be coming from the ZBIS at the area of the flow divider somehow. (The physician called the Cook representative to complain that she is fairly certain now that this is Type 4 endoleak of some kind due to the graft.)

  Patient problems: Clinical Endoleak

  MAUDE report 50423841 ↗
• InjuryJun 1, 2026Device Endoleak

  AS REPORTED PER COMPLAINT EMAIL: "GOOD AFTERNOON. I AM ONCE AGAIN REPORTING MORE FABRIC LEAKS FROM (REDACTED) ENDOGRAFTS. THESE WERE PICKED UP ON FOLLOW UP SCAN TODAY WITH THE SURGEON. THE CASE WAS ORIGINALLY PERFORMED ON (REDACTED). THE ENDOLEAK IS REPORTED TO HAVE PERSISTED FROM THE LIMBS AND ZBIS DEVICES (ZENITH BRANCH ENDOVASCULAR GRAFT ILIAC BIFURCATION, DISTAL DIA 12 MM, COMMON ILIAC SEGMENT LEN 61 MM, EXTERNAL ILIAC SEGMENT LEN 41 MM)." FURTHER INFORMATION PROVIDED STATED: THE PHYSICIAN ATTRIBUTED THE CAUSE TO A FABRIC LEAK IN THE DEVICE. NO PRE-EXISTING ANATOMICAL CONDITIONS (SUCH AS VESSEL CALCIFICATION OR TORTUOSITY) WERE IDENTIFIED, AND NO DIFFICULTIES WERE ENCOUNTERED DURING THE ORIGINAL DEPLOYMENT. TO TREAT THE ENDOLEAK, A 16 MM GRAFT WAS USED TO RELINE THE AFFECTED AREA, AND ADDITIONAL GRAFTS WERE ALSO IMPLANTED AS ADJUNCTIVE MEASURES. NO HIGH BLOOD PRESSURE OR GRAFT OBSTRUCTION WAS OBSERVED DURING THE ENDOLEAK EVENT. THE IMPLANTED DEVICES WERE NOT AVAILABLE FOR RETURN. THE PATIENT CONTINUED TO BE MONITORED FOLLOWING THE INTERVENTION, WITH NO FURTHER ADVERSE OUTCOME NOTED AT THE TIME OF REPORTING.

  Patient problems: Clinical Endoleak

  MAUDE report 25349010 ↗

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

…and 96 more.