Zenith Spiral-Z G55223Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002552231), received between Jun 20, 2016 and May 18, 2023 — classified as 1 death, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Complete Blockage” (1 report).

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.

• InjuryMay 18, 2023Obstruction of Flow; Obstruction of Flow

  A 77-YEAR-OLD MALE WAS DIAGNOSED WITH AN ABDOMINAL AORTIC ANEURYSM AND A LEFT ILIAC ANEURYSM. HE HAD BEEN PRESCRIBED KARDEGIC (ACETYLSALICYLIC ACID LYSINE) 75 MG. HE UNDERWENT AN ENDOVASCULAR AORTIC REPAIR (EVAR) ON (B)(6) 2023. THE FOLLOWING COOK DEVICES WERE PLACED: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (TFFB-24-82, LOT NUMBER 14841907). ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-13-74-ZT, LOT NUMBER 14964326) PLACED ON THE RIGHT. ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-9-122-ZT, LOT NUMBER 14830214) EXTENSION PLACED ON THE RIGHT. ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-16-74-ZT, LOT NUMBER 14995247) PLACED ON THE LEFT. ZENITH BRANCH ENDOVASCULAR GRAFT ILIAC BIFURCATION (RPN: ZBIS-10-45-41, LOT A1121220) PLACED ON THE LEFT . AFTER THE PROCEDURE, THE PATIENT WAS PRESCRIBED KARDEGIC 75 MG AS WELL AS LOVENOX 40 MG DURING HIS HOSPITAL STAY. AFTER DISCHARGE, THE PATIENT WAS PRESCRIBED KARDEGIC 75 MG. IT WAS REPORTED TO COOK THAT THE PATIENT HAD A RIGHT LIMB OCCLUSION AND REQUIRED A RIGHT FEMORAL ARTERY TO LEFT FEMORAL ARTERY BYPASS PROCEDURE. FLOW WAS RESTORED. TH

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16954236 ↗
• DeathMar 12, 2021Complete Blockage; Fluid/Blood Leak; Complete Blockage; Fluid/Blood Leak

  IT WAS REPORTED THAT AN (B)(6) MALE PATIENT WITH A TOTAL OF 5 COOK DEVICES IMPLANTED EXPERIENCED MULTIPLE INSTANCES OF ENDOLEAKS DUE TO COMPONENT SEPARATION AND OCCLUSION OF THE GRAFTS. ON (B)(6) 2021, THE PATIENT PRESENTED IN AN EMERGENCY SITUATION WITH AN ANEURYSM RUPTURE AND THE ABDOMEN FULL OF BLOOD CLOTS, WHICH CONTRIBUTED TO A LACK OF BLOOD FLOW BELOW THE PATIENT'S AORTA. THE PATIENT ULTIMATELY EXPIRED. A TOTAL OF 5 REPORTS WILL BE SUBMITTED UNDER PATIENT IDENTIFIER: (B)(6), ONE FOR EACH DEVICE THE PATIENT HAD IMPLANTED. THIS REPORT CONCERNS THE THROMBUS ASSOCIATED WITH THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG DEVICE PLACED DURING AN INTERVENTION ON (B)(6) 2019. ON (B)(6) 2010, A THEN (B)(6) MALE PATIENT WITH AN ABDOMINAL AORTIC ANEURYSM UNDERWENT A PROCEDURE IN WHICH 4 ZENITH GRAFTS WERE IMPLANTED, LISTED BELOW. MAIN BODY: TFFB-30-111-ZT, LOT 2528519. CONTRALATERAL SIDE PROXIMAL: TFLE-12-90-ZT, LOT 2376696. CONTRALATERAL SIDE DISTAL: TFLE-18-73-ZT, LOT 2459967. IPSILATERAL SIDE: UNKNOWN TFLE. THE PATIENT PRESENTED BACK TO THE IMPLANTING HOSPITAL AND PHYSICIAN APPROXIMATELY 2 YEARS AGO AS THERE WAS A DISCONNECTION OF COMPONENTS AND BLOOD CLOTS

  Patient problems: Obstruction/Occlusion; Ruptured Aneurysm

  MAUDE report 11477831 ↗
• MalfunctionDec 23, 2016Leak/Splash; Deformation Due to Compressive Stress; Device Operates Differently Than Expected; Leak/Splash; Deformation Due to Compressive Stress; Device Operates Differently Than Expected

  AN INTERNATIONAL CUSTOMER REPORTED THAT DURING AN ENDOVASCULAR AORTIC REPAIR, THE RIGHT AND LEFT SPIRAL Z ILIAC LEGS WERE IMPLANTED INTO THE IPSILATERAL BRANCH OF THE MAIN BODY. A KISSING BALLOON TECHNIQUE WAS USED FOR SPIRAL Z ILIAC LEGS DILATATION. THE ILIAC LEGS WERE SEMI COLLAPSED (MEDWATCH1820334-2016-01548, RIGHT LEG, AND MEDWATCH 1820334-2016-01550, LEFT LEG, - THIS REPORT). THE PATIENT WAS ALSO REPORTED TO HAVE A TYPE III ENDOLEAK IN THE MAIN BODY, WHICH IS NOT REPORTED TO FDA SINCE THERE IS NOT A SIMILAR DEVICE THAT IS MARKETED IN THE US. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6202406 ↗
• InjuryJun 20, 2016Hole In Material; Hole In Material

  DURING A EVAR PROCEDURE, A SUSPECTED HOLE IN THE GRAFT CAUSED AN ENDOLEAK . THE ZSLE WAS BALLOONED AND EXTENDED DISTALLY, BUT ENDOLEAK WAS STILL PRESENT. A BALLOON WAS INFLATED IN THE CONTRAGATE AND A RUN DONE FROM BELOW AND THE ENDOLEAK WAS PRESENT. THIS PROVED THAT IT WAS THE LIMB. AN ADDITIONAL 9MM X 107 MM GRAFT WAS IMPLANTED TO RE-LINE THE 9 MM X 122 MM GRAFT AND COVER THE SUSPECTED HOLE IN ORDER TO RESOLVE THE ENDOLEAK. THE LIMB WAS COMPLETELY RELINED AND THE LEAK DISAPPEARED. CLINICIANS THOUGHT ONLY EXPLANATION WAS A DEFECT IN THE LIMB EXTENSION. A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT'S BODY.

  Patient problems: No Code Available

  MAUDE report 5736733 ↗