Zenith Spiral-Z G55236Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002552361), received between Feb 1, 2024 and Jan 9, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2025Fluid/Blood Leak; Device Endoleak; Fluid/Blood Leak; Device Endoleak

  IT WAS REPORTED THAT A TYPE 1B ENDOLEAK WAS IDENTIFIED ON THE LEFT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG DURING A FENESTRATED ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (FEVAR) PROCEDURE ON A 67-YEAR-OLD MALE PATIENT. PRE-PROCEDURE IMAGING WAS COMPLETED ON (B)(6)2024, 112 DAYS PRIOR TO THE PROCEDURE. THE PROXIMAL SEALING ZONE DID NOT HAVE ANY OCCLUSIVE DISEASE OR CALCIFICATION. THROMBUS WAS NOT PRESENT IN THE PROXIMAL SEALING ZONE. THE PROXIMAL SEALING ZONE WAS DESCRIBED AS PARALLEL. THE RIGHT COMMON ILIAC ARTERY, LEFT COMMON ILIAC ARTERY, RIGHT EXTERNAL ILIAC ARTERY, LEFT EXTERNAL ILIAC ARTERY, RIGHT FEMORAL ARTERY, LEFT FORMAL ARTERY DID NOT HAVE ANY CALCIFICATION OR OCCLUSIVE DISEASE. THE ILIAC ARTERIES WERE NOT TORTUOUS. THE AORTA DIAMETER AT THE LOCATION OF THE MAXIMUM ANEURYSM DIAMETER (OUTER-WALL TO OUTER-WALL) WAS 63 MM. THE LENGTH OF THE SUITABLE PROXIMAL SEAL ZONE WAS 50 MM. THE DIAMETER OF THE AORTA AT LOCATION OF MAXIMUM DIAMETER OVER LENGTH OF PROXIMAL SEAL ZONE (OUTER-WALL TO OUTER-WALL) WAS 26 MM. THE DIAMETER OF AORTA AT THE LOCATION OF MINIMUM DIAMETER OVER LENGTH OF PROXIMAL SEAL ZONE (OUTER-WALL TO OUTER-WALL) WAS 24 MM. THE % C

  Patient problems: Clinical Endoleak

  MAUDE report 21111560 ↗
• MalfunctionDec 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Clinical Endoleak

  MAUDE report 20834036 ↗
• InjuryJul 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  COOK WAS NOTIFIED OF A TYPE 3A ENDOLEAK ON A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. THE 78-YEAR-OLD MALE UNDERWENT ENDOVASCULAR AORTIC REPAIR (EVAR) ON (B)(6) 2013 WHERE THE FOLLOWING COOK GRAFTS WERE PLACED: ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY (RPN: ZALB-30-84); ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-16-39-ZT); ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-20-90-ZT); ZENITH BRANCH ENDOVASCULAR GRAFT ILIAC BIFURCATION (RPN: ZBIS-12-45-41). UPON REVIEW OF THE COMPUTED TOMOGRAPHY (CT) IT WAS DETERMINED THAT THERE WAS A TYPE 3A ENDOLEAK ON THE PATIENT'S RIGHT SIDE BETWEEN THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-16-39-ZT) AND THE ZENITH BRANCH ENDOVASCULAR GRAFT ILIAC BIFURCATION (RPN: ZBIS-12-45-41). IT WAS REPORTED THAT THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-16-39-ZT) MAY REQUIRE RELINING. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 19732059 ↗
• MalfunctionMay 2, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2024. IT WAS REPORTED THAT ON THE RIGHT SIDE, DUE TO POOR DISTAL LANDING ZONE (LONG AND TORTUOUS WITH A LARGE DIAMETER OF 24MM) IN THE COMMON ILIAC ARTERY (CIA), A BRANCHED ILIAC GRAFT WAS PLANNED. HOWEVER, TO ACCELERATE THE PROCEDURE, IT WAS DECIDED INTRAOPERATIVELY TO USE A 28MM X 80MM GRAFT TO ACHIEVE A STABLE LANDING ZONE DESPITE THE SIZE OF THE CIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234435 ↗
• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STUDY PATIENT REQUIRED A SURGICAL FEMORAL ENDARTERECTOMY FOR "MOBILISATION OF FEMORAL PLAQUES" AFTER THE PLACEMENT OF COOK DEVICES ON (B)(6) 2023. THE PATIENT WAS 62 YEARS OLD AT THE TIME OF THE CUSTOM-MADE DEVICE PROCEDURE. HE HAD BEEN DIAGNOSED WITH HYPERTENSION AND HAD HISTORY OF OPEN ABDOMINAL SURGERY. THE PATIENTS JUXTARENAL AORTIC NECK MEASURED (<10 MM). HIS ABDOMINAL AORTIC ANEURYSM (AAA) HAD A HISTORY OF GROWTH GREATER THAN OR EQUAL TO 1.0 CM/YEAR. NO REPAIR PROCEDURES HAD BEEN COMPLETED AFTER THE PRIOR ENDOVASCULAR AORTIC REPAIR (EVAR). PRE-PROCEDURE IMAGING USING CONTRAST WAS COMPLETED ON (B)(6) 2023. THE INNOMINATE ARTERY, RIGHT COMMON CAROTID ARTERY, RIGHT SUBCLAVIAN ARTERY, LEFT COMMON CAROTID ARTERY, LEFT SUBCLAVIAN ARTERY, CELIAC ARTERY WERE ALL PATENT AND NO STENOSIS GREATER THAN 50% WAS IDENTIFIED. THE SUPERIOR MESENTERIC ARTERY WAS PATENT AND NO STENOSIS GREATER THAN 50% WAS IDENTIFIED. THE RIGHT RENAL ARTERY WAS PATENT AND NO STENOSIS GREATER THAN 50% WAS IDENTIFIED. THE LEFT RENAL ARTERY WAS PATENT AND NO STENOSIS GREATER THAN 50% WAS IDENTIFIED. THE RIGHT ACCESSORY RENAL ARTERY WAS PATENT AND NO NO STENOSIS GREATER THAN 50% WAS IDENTIFIED

  Patient problems: Paresthesia; Stenosis

  MAUDE report 18625994 ↗