Zenith Spiral-Z G55234Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10827002552347), received between Jan 20, 2015 and Jun 10, 2024 — classified as 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO COOK THAT A TYPE 1B ENDOLEAK ON A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS IDENTIFIED DURING A REINTERVENTION PROCEDURE. THE PATIENT HAD UNDERGONE A PREVIOUS ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE WHERE AN UNKNOWN ILIAC LEG GRAFT WAS IMPLANTED. A TYPE 1B ENDOLEAK ON THE UNKNOWN ILIAC LEG GRAFT WAS IDENTIFIED AND REQUIRED REINTERVENTION. THE PATIENT UNDERWENT THE REINTERVENTION PROCEDURE ON (B)(6) 2024 TO ADDRESS THE TYPE 1B ENDOLEAK. IT WAS REPORTED THAT THERE WAS NO SIGNIFICANT TORTUOSITY OF THE DISTAL AORTA, ILIAC ARTERIES, AND/OR FEMORAL ARTERIES. DURING THE REINTERVENTION PROCEDURE A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG RPN: ZSLE-13-107-ZT WAS IMPLANTED IN THE RIGHT COMMON ILIAC TO ADDRESS THE TYPE 1B ENDOLEAK ON THE PREVIOUSLY IMPLANTED UNKNOWN ILIAC LEG GRAFT. AFTER PLACEMENT OF THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-13-107-ZT), A TYPE 1B ENDOLEAK ON THE NEWLY PLACED DEVICE WAS IDENTIFIED. A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-13-122-ZT) WAS THEN IMPLANTED TO EXTEND THE EXISTING ILIAC LEG GRAFT AND

  Patient problems: Clinical Endoleak

  MAUDE report 19505165 ↗
• MalfunctionJun 29, 2023Fluid/Blood Leak; Separation Problem; Fluid/Blood Leak; Separation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17227521 ↗
• InjuryJun 25, 2021Complete Blockage; Complete Blockage

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

  Patient problems: Insufficient Information; Thrombosis/Thrombus

  MAUDE report 12069763 ↗
• MalfunctionAug 2, 2019Fluid/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: No Code Available

  MAUDE report 8855987 ↗
• MalfunctionApr 24, 2019Break; Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8546423 ↗
• InjuryJun 14, 2018Occlusion Within Device; Occlusion Within Device

  ON (B)(6) 2018, THE PATIENT HAD AN INITIAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. THREE DEVICES WERE IMPLANTED INCLUDING A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY AND TWO ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEGS. AT THE END OF THE INITIAL PROCEDURE THE GRAFTS WERE WIDE OPEN, PATENT AND HAD NO KINKS. ON (B)(6) 2018, ONE WEEK AFTER THE IMPLANT, THE PATIENT CAME TO THE HOSPITAL PRESENTING WITH ONSET OF BILATERAL LOWER EXTREMITY PAIN, NUMBNESS AND MOTOR LOSS. IT WAS THEN DETERMINED THAT THE ENTIRE GRAFT SYSTEM HAD THROMBOSED. THE DIAGNOSIS WAS, AORTIC THROMBOSIS OF BILATERAL LOWER EXTREMITIES AND ACUTE LIMB THROMBOSIS. THE PHYSICIAN ADVISED THAT THE PATIENT WAS COMPLIANT WITH ASPIRIN AND ANTICOAGULANTS. SECONDARY INTERVENTIONS WERE REQUIRED INCLUDING A RIGHT AXIAL BI-FEMORAL BYPASS, BILATERAL LOWER EXTREMITY FOUR COMPARTMENT FASCIOTOMY, LEFT FEMORAL TO ABOVE KNEE BYPASS, THROMBECTOMY OF THE RIGHT SUPERFICIAL FEMORAL ARTERY, THE POSTERIOR TIBIAL ARTERY AND THE ANTERIOR TIBIAL ARTERY. THE PATIENT IS IN CRITICAL CONDITION REQUIRES MEDICAL MANAGEMENT. MFR. REPORT # 1820334-2018-01604 FILED TO REPORT THROMBOSED MAIN BODY, MFR. REPORT # 1

  Patient problems: No Code Available; Pain; Thrombosis

  MAUDE report 7602537 ↗
• InjuryApr 16, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THAT THE FEMALE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2016. AS REPORTED, THE PATIENT DEVELOPED AN EVAR RIGHT LIMB OCCLUSION OF THE IMPLANTED ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. THE PATIENT WAS EXPERIENCING PAIN AND CLAUDICATION. AS A RESULT OF THIS DEVELOPMENT, THE PATIENT HAD AN URGENT FEM-FEM CROSS-OVER SURGICAL PROCEDURE.

  Patient problems: Claudication; Pain

  MAUDE report 7434767 ↗
• InjuryJan 30, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (AAA) USING A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG ON (B)(6) 2017. AS REPORTED, THE PATIENT¿S ANATOMY HAD A STENOSIS AND THE LIMB SUBSEQUENTLY OCCLUDED DUE TO THROMBUS DISTAL TO THE AORTIC BIFURCATION IN THE RIGHT ILIAC LIMB. THE PATIENT HAD AN UNSUCCESSFUL THROMBOLYSIS AND STENT PROCEDURE. A FEM-FEM BYPASS WILL BE PERFORMED TO RE-VASCULARIZE THE RIGHT LEG. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT OUTCOME OF THE SECONDARY PROCEDURE BUT HAS NOT BEEN RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: No Code Available; Stenosis; Thrombus

  MAUDE report 7228344 ↗
• InjuryNov 8, 2017Detachment Of Device Component; Material Separation; Detachment Of Device Component; Material Separation

  THE USER FACILITY REPORTED THAT ON (B)(6) 2017, A (B)(6), MALE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) AND A RIGHT COMMON ILIAC ARTERY (CIA) ANEURYSM. THE PATIENT WAS SUITABLE FOR THE PROCEDURE. SINCE THE RIGHT EXTERNAL ILIAC ARTERY (EIA) WAS TORTUOUS, ANOTHER MANUFACTURER'S LEG GRAFT WAS SELECTED FOR THE PATIENT'S BENEFIT. THE DEVICES WERE PLACED AS FOLLOWS; ZENITH MAIN BODY BY RIGHT APPROACH, ZENITH SPIRAL-Z ILIAC LEG IN THE LEFT CIA, ZENITH SPIRAL Z ILIAC LEG IN THE RIGHT CIA, AND ANOTHER MANUFACTURER'S DEVICE IN THE RIGHT EIA. BOTH ANGIOGRAPHY¿S DURING THE PROCEDURE AND THE FINAL CONFIRMATORY ANGIOGRAPHY SHOWED NO UNKNOWN SUBSTANCE IN THE PATIENT. ON (B)(6) 2017, A FOLLOW-UP CT REVEALED AN UNKNOWN SUBSTANCE STUCK BETWEEN THE OTHER MANUFACTURER'S IN THE LEFT EXTERNAL ILIAC ARTERY AND VESSEL WALL IN THE DORSAL SIDE. THE PHYSICIAN HAS DECIDED TO TAKE A WAIT-AND-SEE APPROACH WITHOUT ANY TREATMENT. THE SUBSTANCE REMAINS IN THE PATIENT. HOWEVER, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED DUE TO THIS EVENT. ACCORDING TO AN IMAGING REVIEW DATED (B)(6) 2017, A TUBULAR FRAGMENT WITH DENSITY CONSISTENT WITH PLAST

  Patient problems: Foreign Body In Patient

  MAUDE report 7010507 ↗
• MalfunctionJul 18, 2017Fluid/Blood Leak; Flushing Problem

  THE INFORMATION PROVIDED INDICATED THAT THE DEVICE COULD NOT BE FLUSHED AND SALINE WAS LEAKING FROM THE HEMOSTASIS VALVE. THE DEVICE WAS REMOVED FROM THE PATIENT AND A DIFFERENT ONE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6723277 ↗
• 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 1820334-2016-01299 AND 1820334-2016-01298, 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; No Code Available

  MAUDE report 6100627 ↗
• InjuryJan 20, 2015Activation, Positioning or Separation Problem

  A 78 YEAR OLD MALE UNDERWENT AN EVAR ON (B)(6) 2014. A ZENITH FLEX MAIN BODY (1820334-2015-00038) WAS PLACED BY THE PHYSICIAN WITH NO ISSUES. THE CONTRALATERAL GATE WAS ACCESS AND AMPLATZ WIRE PLACED. THE ZENITH ILIAC LEG GRAFT WITH SPIRAL-Z TECHNOLOGY WAS INSERTED AND RESISTANCE WAS MET. THE WIRE WAS REPOSITIONED TWICE AND ATTEMPTED TWO MORE TIMES. THE DECISION WAS MADE TO RETRIEVE THE TOP CAP FROM IPSILATERAL SIDE. THE TRIGGER WIRE WAS RELEASED AND GREY POSITIONER WAS ADVANCED. HALFWAY UP, THE ENTIRE GRAFT MOVED UP ENCROACHING ON RIGHT RENAL AND SMA. A CODA BALLOON WAS INSERTED ON THE CONTRALATERAL SIDE AND THE GRAFT WAS PULLED DOWN AND STRAIGHTENED. THE PHYSICIAN PROCEEDED WITH A THIRD ATTEMPT TO INSERT A NEW ZENITH ILIAC LEG GRAFT WITH SPIRAL-Z TECHNOLOGY (1820334-2015-00054), BUT WAS UNABLE TO FULLY INSERT. THE DECISION WAS MADE TO BRIDGE THE GAP WITH AN ICAST COVERED STENT. SEVERAL ATTEMPTS WAS MADE WITH THE WIRE AND CATHETER TO CANNULATE THE SMA AND RIGHT RENAL ARTERY THAT WERE COVERED WITH NO SUCCESS. FINALLY THE ZENITH ILIAC LEG GRAFT WAS PLACED IN THE IPSILATERAL SIDE. THE GRAFT WAS BALLOONED WITH A CODA AND A FINAL ANGIO WAS PERFORMED. THE SMA WAS OCCLUDED AND PARTIAL RI

  Patient problems: Other (for use when an appropriate patient code cannot be identified)

  MAUDE report 4452598 ↗
• InjuryJan 20, 2015Leak/Splash

  AN (B)(6) MALE UNDERWENT AN ABDOMINAL AORTIC ANEURYSM REPAIR ON (B)(6) 2014. WHEN IMPLANTATION OF THE MAINBODY GRAFT AND TWO LEG GRAFTS (ONE ON EACH SIDE) WAS COMPLETED, BALLOONING OF PROXIMAL SEAL ZONE, OVERLAPS AND DISTAL SEALS WERE PERFORMED. ADDITIONALLY, BALLOONING OF THE LEG WAS PERFORMED THROUGHOUT THE LENGTH OF THE STENT-GRAFT ON THE RIGHT SIDE. FINAL ANGIO WAS PERFORMED WITH CONTRAST USING FLUSH PIG CATHETER PROXIMAL TO RENAL ARTERIES. BLUSHING WAS OBSERVED AT THE MID-SECTION OF THE LEG GRAFT ON THE RIGHT SIDE. AN ADDITIONAL RETROGRADE SHEATH ANGIOGRAM WAS PERFORMED FOR MORE DETAIL. THE ANGIO SHOWED A SMALL JET OF CONTRAST ESCAPING FROM THE MID PORTION OF THE LEG GRAFT. AN ADDITIONAL LEG GRAFT WAS PLACED ON THE RIGHT SIDE. BALLOONING OF PROXIMAL OVERLAP AND DISTAL SEAL WAS PERFORMED. FINAL ANGIO ON RIGHT SIDE SHOWED NO SIGNS OF LEAK.

  Patient problems: Surgery, prolonged

  MAUDE report 4452563 ↗