COOK G60340Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002603400), received between Jan 26, 2026 and Mar 4, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.

• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  DESCRIPTION OF EVENT PER THE COMPLAINT EMAIL: DR HOSP UNC IDE PRELOADED FEN PROX CASE WITH ZBIS RT ILIAC. PRODUCT: ZBIS-10-45-41-US LOT A1201336 LONG STORY BUT DURING THE ADVANCING THE ZBIS THE OPERATOR THOUGHT THAT THE DILATOR HIT THE RT RENAL AND SMA BRANCH STENTS. AT THE END OF PROCEDURE, THEY ASSESS THE STATUS OF THE BRANCHES. THEY CONFIRMED THE SMA WAS OCCLUDED. SEVERAL ATTEMPTS WERE MADE AND EVENTUALLY GAINED ACCESS AND REPAIRED THE SMA STENT. PATIENT WAS COMPLETED WITHOUT ANY COMPLICATIONS. PATIENT OUTCOME: THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.

  Patient problems: Insufficient Information

  MAUDE report 24512429 ↗
• MalfunctionMar 4, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE ADVANCING THE ZBIS THE OPERATOR THOUGHT THAT THE DILATOR HIT THE RT RENAL AND SMA BRANCH STENTS . AT THE END OF PROCEDURE THEY ASSESS THE STATUS OF THE BRANCHES. THEY CONFIRMED THE SMA WAS OCCLUDED. SEVERAL ATTEMPTS WERE MADE AND EVENTUALLY GAINED ACCESS AND REPAIRED THE SMA STENT. PATIENT WAS COMPLETED WITHOUT ANY COMPLICATIONS.

  Patient problems: Insufficient Information

  MAUDE report 24510711 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking

  THE ICAST STENT (NOT A COOK MANUFACTURED DEVICE) IN THE INTERNAL ILIAC AND THE SIDE BRANCH OF THE ZBIS GRAFT WAS DEPLOYED BEFORE THE THROUGH AND THROUGH CATHETER WAS REMOVED. UPON REMOVAL OF THE DILATOR TO THE MAIN DEVICE, THE CATHETER BECAME TRAPPED BEHIND THE ICAST STENT AND SNAPPED - BETWEEN THE STENT AND THE SIDE BRANCH.THE PIECE OF THE CATHETER IS TRAPPED BEHIND THE ICAST STENT INSIDE THE SIDE BRANCH OF THE ILIAC BRANCH DEVICE. FURTHER INFORMATION PROVIDED STATES:ON (b)(6) 2026, A COOK ZENITH BRANCH ILIAC STENT (LOT A1199911) WAS IMPLANTED IN A PATIENT WITH A PRE-EXISTING AORTO-ILIAC ANEURYSM. THE PROCEDURE ALSO INVOLVED USE OF ANOTHER MANUFACTURER'S STENT, STENT-GRAFT, SHEATH, AND A COOK INDY OTW SNARE. A COOK REPRESENTATIVE WAS PRESENT, AND THE SAME DAY THE TEAM NOTED A DEVICE-RELATED NONCONFORMANCE; HOWEVER, NO ADVERSE EVENTS OCCURRED, AND NO ADDITIONAL PROCEDURES WERE REQUIRED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24194164 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORTER: THE ICAST STENT IN THE INTERNAL ILIAC AND THE SIDE BRANCH OF THE ZBIS WAS DEPLOYED BEFORE THE THROUGH AND THROUGH CATHETER WAS REMOVED. UPON REMOVAL OF THE DILATOR TO THE MAIN DEVICE, THE CATHETER BECAME TRAPPED BEHIND THE STENT (ANOTHER MANUFACTURER) AND SNAPPED- BETWEEN THE STENT AND THE SIDE BRANCH. THE PIECE OF THE CATHETER IS TRAPPED BEHIND THE ICAST STENT INSIDE THE SIDE BRANCH OF THE ILIAC BRANCH DEVICE. FURTHER INFORMATION PROVIDED STATES: ON (B)(6) 2026, A COOK ZENITH BRANCH ILIAC STENT (LOT A1199911) WAS IMPLANTED IN A PATIENT WITH A PRE-EXISTING AORTO-ILIAC ANEURYSM. THE PROCEDURE ALSO INVOLVED USE OF ANOTHER MANUFACTURER'S STENT, STENT-GRAFT, SHEATH, AND A COOK INDY OTW SNARE. A COOK REPRESENTATIVE WAS PRESENT, AND THE SAME DAY THE TEAM NOTED A DEVICE-RELATED NONCONFORMANCE; HOWEVER, NO ADVERSE EVENTS OCCURRED, AND NO ADDITIONAL PROCEDURES WERE REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24176416 ↗

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-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-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-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-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-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-3139-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-10-71-ZT, REF G48444, 14 Fr ID/ 5.3 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-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-3146-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-18-73-ZT, REF G48466, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3150-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48473, 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-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-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-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-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.

…and 96 more.