Zenith Spiral-Z G55235Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10827002552354), received between Apr 27, 2015 and May 7, 2024 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Occlusion Within Device” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED TO COOK THAT THE LENGTH MEASUREMENT FOR A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS INCORRECT. A 75-YEAR-OLD MALE PATIENT UNDERWENT AN ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE TO TREAT AN ABDOMINAL AND ILIAC ANEURYSM. FIRST A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG RPN: ZSLE-13-107-ZT WAS IMPLANTED IN THE RIGHT COMMON ILIAC. NEXT A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG RPN: ZSLE-13-122-ZT WAS IMPLANTED. RADIOLOGICAL GUIDANCE AND PHYSICIAN MEASUREMENTS WERE COMPLETED TO COMPARE THE GRAFT LENGTHS. IT WAS DETERMINED BY THE PHYSICIAN THAT THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG RPN: ZSLE-13-122-ZT WAS THE SAME LENGTH AS THE PREVIOUSLY PLACED ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG RPN: ZSLE-13-107-ZT. DESPITE THE DIFFERENTIAL IN LENGTH, THE DEVICE REMAIN IMPLANTED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19261067 ↗
• InjuryOct 25, 2023Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: Clinical Endoleak

  MAUDE report 18007162 ↗
• MalfunctionMay 27, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IN ADDITIONAL INFORMATION, IT WAS REPORTED THE PATIENT HAD MINIMAL VESSEL TORTUOSITY. PROVIDED IMAGING CLARIFIED THE GRAFT LANDED APPROXIMATELY 3CM SHORT OF THE INTENDED LANDING ZONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11897681 ↗
• InjuryJul 3, 2020Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS TORN AND THUS OBSERVED LEAKING FOLLOWING IMPLANTATION. THE DEVICE WAS IMPLANTED THROUGH THE PATIENT'S LEFT EXTERNAL ILIAC ARTERY ALONG WITH ANOTHER LEG GRAFT. FOLLOWING IMPLANTATION, A BALLOON WAS USED TO "LEVERAGE THE UNION" BETWEEN THE GRAFTS. CONTRAST INJECTION WAS THEN PERFORMED, WHICH REVEALED A TYPE 3B ENDOLEAK. BALLOONING WAS REPEATED AND FOLLOWED BY MORE CONTRAST INJECTION, WHICH SHOWED PERSISTENCE OF THE ENDOLEAK. INJECTIONS WERE THEN PERFORMED WITH THE "ARCH OBLIQUE", BUT THE LEAK STILL PERSISTED. IT WAS THEN CONCLUDED THAT THERE WAS A TEAR WITHIN THE GRAFT FABRIC. THE GRAFT WAS LEFT IMPLANTED IN THE PATIENT, THOUGH ANOTHER EXTENSION GRAFT WAS PLACED. THE PATIENT REQUIRED A BLOOD TRANSFUSION AND RETROPERITONEAL HEMATOMA DRAINAGE AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION REGARDING THE PATIENT, DEVICE, AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10227786 ↗
• InjurySep 21, 2017Occlusion Within Device; Occlusion Within Device

  THE USER FACILITY REPORTED THE PATIENT UNDERWENT ENDOVASCULAR ANEURYSM REPAIR (EVAR) ON (B)(6) 2017. AS REPORTED, THERE WERE BLOOD CLOTS ATTACHED TO THE ACCESS ROUTE, SO THE STATE OF THE ACCESS ROUTE WAS NOT VERY GOOD. BUT AS MILD AS THE DELIVERY SYSTEM OF THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG IS THE DEVICE WOULD BE ABLE TO ADVANCE. THE PATIENT WAS JUDGED TO BE SUITABLE FOR THE PROCEDURE. ON (B)(6) 2017, A COMPUTED TOMOGRAPHY (CT) WAS PERFORMED BECAUSE THE PATIENT COMPLAINED ABOUT PAIN IN THE RIGHT LEG. THROMBOSIS WAS CONFIRMED INSIDE THE IPSILATERAL ILIAC LEG GRAFT (SUBJECT OF THIS REPORT). ALSO, THE PHYSICIAN OBSERVED THAT THE IPSILATERAL LIMB OF THE MAIN BODY (TFB-28-74-ZT) NARROWED BY PRESSURE DERIVED FROM EXPANSIVE FORCE WHICH GREW AT THE OVERLAPPED POINT BETWEEN THE CONTRALATERAL LIMB OF THE MAIN BODY AND THE CONTRALATERAL ILIAC LEG GRAFT (1820334-2017-02880). THROMBUS ASPIRATION WAS PERFORMED AS AN EMERGENCY TREATMENT AND A 12MM BARE STENT WAS ADDITIONALLY PLACED IN THE NARROWED SITE OF THE IPSILATERAL LIMB TO SECURE THE INNER LUMEN OF THE LIMB. A CT WAS PERFORMED ON (B)(6) 2017 AND CONFIRMED BLOOD FLOW AND THE NARROWING OF THE IPSILATERAL

  Patient problems: No Code Available; Pain; Thrombosis

  MAUDE report 6883986 ↗
• InjuryNov 14, 2016Leak/Splash; Leak/Splash

  THIS EVENT WAS ORIGINALLY FILED AS MEDWATCH 1820334-2016-01110, AFTER FURTHER INVESTIGATIONAL AND CLINICAL REVIEW OF THE ORIGINAL RECORD IT WAS CONFIRMED AN ENDOLEAK WAS PRESENT THROUGH ALL THREE COMPONENTS. TWO ADDITIONAL MEDWATCH REPORTS, THIS RECORD 1820334-2016-01298 AND 1820334-2016-01299, ARE BEING FILED AS PART OF THE ORIGINAL INCIDENT TO FURTHER ADDRESS THE ADDITIONAL TWO COMPONENTS. EVENT: IT WAS REPORTED A FEMALE PATIENT HAD ENDOVASCULAR ANEURYSM REPAIR (EVAR). AFTER THREE GRAFTS WERE PLACED, THE PHYSICIAN CONFIRMED PROXIMAL TYPE I ENDOLEAK AND TYPE IV ENDOLEAK FROM ALL 3 STENT GRAFTS THROUGH ANGIOGRAPHY. THE PROXIMAL TYPE I ENDOLEAK WAS GONE AFTER ADDITIONAL BALLOONING AT THE PROXIMAL NECK, ATTEMPTS TO SOLVE THE TYPE IV ENDOLEAK WITH FURTHER PLACEMENT WERE UNSUCCESSFUL. THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-SEE APPROACH AND COMPLETED THE PROCEDURE. THE PATIENT HAS NOT SHOWN ANY PROBLEMATIC SYMPTOMS. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Aneurysm

  MAUDE report 6100623 ↗
• MalfunctionOct 20, 2016Delivery System Failure; Delivery System Failure

  IT WAS NOT POSSIBLE TO REMOVE THE STYLET FROM INTRODUCTION SYSTEM. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6043206 ↗
• InjuryOct 18, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A (B)(6) YEARS OLD MALE PATIENT UNDERWENT A GRAFT PLACEMENT PROCEDURE. DURING THE PROCEDURE, THE USER DISCOVERED THAT THE GRAFT WAS TOO SHORT. THE STENT WAS APPROXIMATELY 22 MM TOO SHORT. THE LABEL STATES THAT THE LENGTH SHOULD BE BETWEEN 13-122 MM. THE INCORRECT LENGTH WAS CONFIRMED AFTER THE INSIDE AND OUTSIDE OF THE PATIENT'S ANATOMY WAS MEASURED. THE GRAFT WAS IMPLANTED IN THE PATIENT ALONG WITH A SECOND GRAFT. THUS, THE ADDITION OF THE SECOND GRAFT ACHIEVED THE REQUIRED NEEDED LENGTH FOR THE PATIENT. A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT'S BODY.

  Patient problems: No Code Available

  MAUDE report 6037779 ↗
• InjuryAug 16, 2016Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT CAME TO HOSPITAL ON (B)(6) 2016 AND RECEIVED A THROMBOLYSIS, DUE TO A LEFT LIMB OCCLUSION. THE PATIENT UNDERWENT DE-CLOTTING OF LEFT LIMB AND ADJUNCT STENTING. IT WAS UNCERTAIN IF FEM-FEM BYPASS WAS REQUIRED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING PATIENT OUTCOME.

  Patient problems: No Code Available; Occlusion

  MAUDE report 5878153 ↗
• InjuryJun 19, 2015Occlusion Within Device

  (B)(4): THIS (B)(6) MALE PRESENTED AT THE TIME OF ENROLLMENT WITH A 4.4 CM AORTIC ANEURYSM. THE PROXIMAL NECK HAD A PARALLEL SHAPE WITH NO PLAQUE/THROMBUS. THE LEFT ILIAC ARTERY HAD MILD TORTUOSITY, MILD CALCIFICATION, AND NO OCCLUSIVE DISEASE. THE RIGHT ILIAC ARTERY HAD MILD TORTUOSITY, MILD CALCIFICATION, AND NO OCCLUSIVE DISEASE. ON (B)(6) 2014 (DAY OF PROCEDURE), UNDER GENERAL ANESTHESIA, THE PT RECEIVED A MAIN-BODY GRAFT, A CONTRALATERAL ILIAC LEG GRAFT, AND AN IPSILATERAL ILIAC LEG GRAFT. THE SITE NOTED DIFFICULTY DEPLOYING THE SUPRARENAL BARE STENT. PER THE SITE, THEY WERE "UNABLE TO WITHDRAW BOLD TRIGGER WIRES/RELEASE MECHANISM WITHOUT EXCESSIVE FORCE." BILATERAL ILIAC ANGIOPLASTY WITH A COMPLIANT BALLOON WAS USED WITHOUT COMPLICATIONS OR DIFFICULTIES. AT THE COMPLETION OF THE PROCEDURE, THE GRAFT WAS FULLY IMPLANTED AND PATENT WITH NO ENDOLEAKS OR KINKS. THE PT WAS DISCHARGED THE NEXT DAY AND NO ADVERSE EVENTS WERE REPORTED. ON (B)(6)2014 (22 DAYS POST PROCEDURE), THE ONE MONTH FOLLOW-UP CLINICAL EXAM, BLOOD WORK AND IMAGING WERE COMPLETED. THE PHYSICAL EXAM WAS UNREMARKABLE. THE PT'S CREATININE WAS 1.1 MG/DL. THE PT HAD NOT BEEN HOSPITALIZED NOR HAD ANY SIGNIFICANT MED PR

  Patient problems: Claudication; Insufficient Information

  MAUDE report 4860166 ↗
• InjuryApr 27, 2015Occlusion Within Device

  A (B)(6) MALE PT IN THE SPIRAL-Z POST-MARKET REGISTRY EXPERIENCED CLAUDICATION. THE PT WAS TREATED ON (B)(6) 2014 FOR AN AORTOILIAC ANEURYSM. THE MAXIMUM AORTIC DIAMETER WAS 52 MM. THE PROXIMAL NECK HAD A PARALLEL SHAPE WITH NO THROMBUS. THE BILATERAL ILIAC ARTERIES HAD MILD TORTUOSITY, NO OCCLUSIVE DISEASE, AND MILD CALCIFICATION. THE PT RECEIVED A MAIN-BODY DEVICE, A LEFT ILIAC LEG, A RIGHT ILIAC LEG, AND A LEFT ILIAC LEG EXTENSION. THERE WAS NO DIFFICULTY DEPLOYING ANY OF THE COMPONENTS. NO OTHER PROCEDURES WERE PERFORMED AND NO ADDITIONAL DEVICES WERE USED. A MOLDING BALLOON WAS USED BUT NO DETAILS WERE PROVIDED REGARDING ITS USE. AT THE CONCLUSION OF THE PROCEDURE, THE DEVICES WERE PATENT WITH NO EXTERNAL COMPRESSION, FLOW-LIMITING KINKS, ENDOLEAKS OR THROMBUS. ON (B)(6) 2014 (14 DAYS POST-PROCEDURE), THE PT EXPERIENCED CLAUDICATION (LOWER LIMB OR BUTTOCK). NO OTHER INFORMATION REGARDING THE EVENT IS AVAILABLE. ON (B)(6) 2014 (75 DAYS POST-PROCEDURE), THE PT WAS SEEN IN FOLLOW-UP. THERE HAD BEEN NO CHANGE IN THE SIZE OF THE ANEURYSM. THE DEVICES WERE PATENT WITH NO EXTERNAL COMPRESSION, FLOW-LIMITING KINKS, ENDOLEAK OR MIGRATION. EVIDENCE OF THROMBUS WAS NOTED IN THE RIGHT ILI

  Patient problems: Claudication

  MAUDE report 4746001 ↗