Zenith Spiral-Z G55233Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10827002552330), received between Jun 13, 2016 and Jan 10, 2024 — classified as 9 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2024Complete Blockage; Complete Blockage

  THE PATIENT HAD A COMPUTED TOMOGRAPHY (CT) SCAN COMPLETED FOR PLANNING AND SIZING FOR AN UPCOMING EVAR ON (B)(6) 2014. THE PATIENT WAS 73 YEARS OLD AT THE TIME OF PLANNING AND SIZING. HE UNDERWENT AN ENDOVASCULAR AORTIC REPAIR (EVAR) ON (B)(6) 2015 WHERE COOK DEVICES WERE PLACED. THE PATIENT WAS COMPLIANT WITH POST OPERATIVE FOLLOW UP. EIGHT YEARS AFTER THE INDEX PROCEDURE (DATE UNKNOWN), THE PATIENT WAS SYMPTOMATIC AND REQUIRED HOSPITAL ADMISSION. IT WAS DISCOVERED THAT THE SUPRARENAL STENT ON THE COOK MAIN BODY GRAFT HAD DETACHED FROM THE FABRIC OF THE MAIN BODY GRAFT. DURING THE MANUFACTURER'S INVESTIGATION INTO THE SUPRARENAL STENT SEPARATION, IMAGING WAS PROVIDED. THE IMAGING WAS REVIEWED AND INDICATED COMPLETE OCCLUSION OF THE LEFT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. THERE APPEARED TO BE PROGRESSIVE DISEASE OF THE ANEURYSM AND THROMBUS WAS PRESENT IN THE AORTIC NECK. THE CUSTOMER REPORTED THAT THE PATIENT WOULD REQUIRE AN AORTIC CUFF TO ADDRESS THE SEPARATION. IT IS EXPECTED THAT THE OCCLUDED ILIAC LEG WILL BE TREATED WHEN THE AORTIC CUFF IS PLACED. THE FOCUS OF THIS REPORT IS THE OCCLUDED LEFT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVA

  Patient problems: Obstruction/Occlusion

  MAUDE report 18485496 ↗
• MalfunctionDec 20, 2023Fluid/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 18368389 ↗
• MalfunctionSep 22, 2020Complete Blockage; Complete Blockage

  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 10570499 ↗
• MalfunctionJan 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  UPON DEVICE RECEIPT, AN INSPECTION WAS COMPLETED CONFIRMING THAT THE LEAK FOR THE COMPLAINT DEVICE DID NOT COME FROM THE VALVE BUT RATHER FROM THE PIN VISE. THE FAILURE MODE "PIN VISE LEAKS" FOR THIS DEVICE DOES NOT MEET THE QUALIFICATIONS FOR A REPORTABLE PRODUCT MALFUNCTION. THEREFORE, NO FURTHER REPORTS CONCERNING THIS EVENT WILL BE SUBMITTED.

  Patient problems: No Patient Involvement

  MAUDE report 9627310 ↗
• InjuryOct 30, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  NO ADDITIONAL PATIENT/EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT AS SENT.

  Patient problems: Low Blood Pressure/ Hypotension; No Code Available

  MAUDE report 9255573 ↗
• MalfunctionFeb 12, 2019Obstruction of Flow; Obstruction of Flow

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Pain

  MAUDE report 8331740 ↗
• InjuryOct 3, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED AN (B)(6)-YEAR-OLD MALE PATIENT UNDERWENT EVAR BY LEFT APPROACH. THE PATIENT WAS JUDGED TO BE NOT SUITABLE FOR THE PROCEDURE DUE TO THE BILATERAL COMMON ILIAC ARTERY ANEURYSM (BIL. CIAA). HOWEVER, EVAR WAS SELECTED BECAUSE IT WOULD HAVE BEEN HIGHLY RISKY TO PERFORM ABDOMINAL OPEN SURGERY DUE TO THE PATIENT'S ADVANCED AGE. THE DIAMETER OF ACCESS VESSELS WAS DEEMED APPROPRIATE FOR THE PROCEDURE. IT WAS REPORTED THAT A PART OF THE LEFT EXTERNAL ILIAC ARTERY HAD CALCIFICATION BUT THERE WAS NO SIGNIFICANT TORTUOSITY OF THE PATIENT'S VESSELS WERE NOTED. THE SHAPE OF THE NECK ANATOMY WAS NOTED TO BE NORMAL WITH NO SPECIFIC ANATOMICAL FORM OBSERVED. THE PATIENT DID NOT HAVE ANTI-PLATELET OR ANTI-COAGULATION THERAPY BEFORE OR AFTER THE EVAR PROCEDURE. HOWEVER THEY WERE ADMINISTERED (ACT 200 ~250) OF HEPARIN DURING THE EVAR PROCEDURE. THE PROCEDURE WAS CONDUCTED AS FOLLOWS; PLACING TFFB-26 -82-ZT , ZSLE-13-122-ZT + ZSLE-13-74-ZT CONTRALATERAL, AND ZSLE-13-90-ZT IPSILATERAL. PLACING TWO CONTRALATERAL LEG GRAFTS HAD BEEN PLANNED PRIOR TO THE PROCEDURE SINCE THE PHYSICIAN THOUGHT PLACING ONLY ZSLE-13-122-ZT WOULD BE SHORT. A CODA (32MM-120CM) WAS USED IN THE PROXIMAL NECK AND CO

  Patient problems: No Code Available

  MAUDE report 7930596 ↗
• 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 7602489 ↗
• MalfunctionJan 2, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS DIFFICULT TO DEPLOY DURING AN ABDOMINAL ANEURYSM REPAIR PROCEDURE. THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY WAS PLACED PER THE INSTRUCTION FOR USE (IFU) WITHOUT INCIDENT. AFTER SUCCESSFUL CANNULATION OF THE CONTRALATERAL LIMB, THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE) WAS ADVANCED OVER THE WIRE GUIDE TO THE IFU SUGGESTED PROPER OVERLAP WHERE THE GOLD MARKER WAS ALIGNED WITH THE CONTRALATERAL GATE CHECKMARK. THE SHEATH WAS RETRACTED IN NORMAL FASHION AND THE LIMB EXPANDED IN THE CORRECT POSITION. UPON ATTEMPTING TO REMOVE THE DILATOR TIP OF THE DEVICE BY PULLING DOWN ON THE METAL CANNULA, THE PHYSICIAN EXPERIENCED RESISTANCE. THE POSSIBILITY OF THE BOTTOM OF THE DILATOR TIP BEING CAUGHT ON THE FABRIC WAS DISCUSSED AND THE THOUGHT WAS TO LOOSEN THE PIN VICE, ADVANCE THE GREY POSITIONER UP TO THE DILATOR TIP TO ALLEVIATE THE PERCEIVED ISSUE. THE PIN VICE WAS LOOSENED AND THE PHYSICIAN ATTEMPTED TO ADVANCE THE GREY POSITIONER. THE BOTTOM OF THE LIMB STARTED TO PUSH UP WITH EACH ATTEMPTED ADVANCEMENT OF THE POSITIONER. ONCE AGAIN TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7156994 ↗
• InjurySep 21, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR PROCEDURE ON (B)(6) 2017. AS REPORTED, THE PATIENT WAS SUITABLE FOR THE PROCEDURE. A BLOOD FLOW WHICH LOOKED JETTING FROM THE LEG GRAFT WAS CONFIRMED DURING THE PROCEDURE, SO THE ENDOLEAK WAS STATED AS TYPE IV ENDOLEAK. A POST-PROCEDURAL CT WAS PERFORMED ON (B)(6) 2017 AND CONFIRMED THAT THE ENDOLEAK REMAINS. THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-SEE APPROACH, BUT BECAUSE ANEURYSM ENLARGEMENT WAS CONFIRMED, HOSPITALIZATION WAS PROLONGED. (DIAMETER OF THE RIGHT COMMON ILIAC ARTERY ENLARGED FROM 40MM TO 43MM) AS OF (B)(6) 2017, THE PATIENT HAS NOT YET RECOVERED. THE USER FACILITY HAS ADVISED THE NEXT CT IS SCHEDULED FOR (B)(6) 2017. IF THE TYPE IV ENDOLEAK IS NOT RESOLVED OR ANEURYSM ENLARGEMENT IS CONFIRMED, AN ILIAC LEG GRAFT WILL BE ADDITIONALLY PLACED INSIDE THE PREVIOUSLY PLACED STENT GRAFT. THE PHYSICIAN COMMENTED THAT THE POSSIBILITY OF TYPE II OR TYPE III ENDOLEAK IS LOW. I HAVE NEVER EXPERIENCED TYPE IV THAT WOULD NOT DISAPPEAR ONE WEEK AFTER THE PROCEDURE. FOLLOW-UP WITH THE USER FACILITY HAS BEEN PERFORMED AND ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT CT IMAGING HAS CONFIRMED THAT THE T

  Patient problems: No Code Available

  MAUDE report 6882622 ↗
• InjuryJul 19, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN ILIAC LIMB EXTENSION PROCEDURE WAS DONE WITH A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. OTHER DEVICES USED DURING THIS PROCEDURE INCLUDED AN INTRODUCER, LUNDERQUIST STRAIGHT, AND 32MM CODA BALLOON. THE PHYSICIAN SUSPECTED A HOLE IN THE GRAFT WAS CAUSING A TYPE 3 ENDOLEAK. THE GRAFT WAS RE-LINED WITH ANOTHER MANUFACTURER'S DEVICE. THIS REPORT IS RELATED TO THE REPORT WITH THE MANUFACTURER REPORT NUMBER:1820334-2017-02055.

  Patient problems: No Code Available

  MAUDE report 6726204 ↗
• InjuryJun 30, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ABDOMINAL AORTIC ANEURYSM REPAIR, A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS INSERTED INTO THE PATIENT'S RIGHT COMMON ILIAC. THE DEVICE DEPLOYED SUCCESSFULLY. UPON PUTTING IN THE CODA AND INFLATING THE CODA BALLOON, THE GRAFT RUPTURED IN THE MIDDLE AT THE SPIRAL- Z-STENTS. DUE TO THE RUPTURE, ANOTHER ZSLE WAS IMPLANTED AND SUCCESSFULLY DEPLOYED. THERE WAS NO UNINTENDED SECTION OF THE DEVICE REMAINING INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6682432 ↗
• MalfunctionMay 12, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE PREPPING THE DEVICE WITH HEPARINIZED SALINE FOR THE ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE THE PA-C WAS UNABLE TO FLUSH THROUGH THE CAPTOR VALVE. THE PHYSICIAN ALSO ATTEMPTED TO FLUSH THE DEVICE WITHOUT SUCCESS. THE MEDICAL TEAM NOTICED THAT THE CAPTOR VALVE HAD A SLOW LEAK AT THE CLEAR PART OF THE VALVE WHERE IT MET WITH THE GREY RING. THEY WERE UNCOMFORTABLE USING THE DEVICE FOR THE PROCEDURE AND INSTEAD EXCHANGED IT FOR A NEW DEVICE OF THE SAME SIZE. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. OF NOTE, THE COMPLAINT DEVICE NEVER CAME INTO CONTACT WITH THE PATIENT AND WAS NEVER DEPLOYED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6564558 ↗
• InjuryAug 16, 2016Leak/Splash; Leak/Splash

  AFTER A SUCCESSFUL PROCEDURE, THE USER FACILITY NOTICED AN ENDOLEAK IN THE GRAFT. AFTER TAKING ONE MORE SHOT WITH THE CATHETER IN THE LEG EXTENSION IT SHOWED A TYPE 3 ENDOLEAK WITH A CLEARL BLUSH FROM THE LEG EXTENSION INTO THE ILIAC ANEURYSM. THE LEAK WAS REPORTEDLY REPAIRED BY USING AN ADDITIONAL LEG EXTENSION. AFTER THE NEW LEG EXTENSION, THERE WAS NO ENDOLEAK VISIBLE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE .

  Patient problems: No Code Available

  MAUDE report 5878794 ↗
• InjuryJun 13, 2016Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  DURING A AAA PROCEDURE, AFTER THE MAIN BODY WAS PLACED, THE 13 MM X 90 MM ILIAC LEG GRAFT WAS PLACED, BUT IT WAS MUCH TOO SHORT. INTRAOPERATIVE, THE PHYSICIAN MEASURED THE LEG GRAFT IN THE X-RAY WITH A CENTIMETER SIZING CATHETER. HE MEASURED A 74MM LONG LEG INSTEAD OF A 90MM LEG. THE LEG IMPLANTED WAS A 13 MM X 74 MM AND NOT A 13 MM X 90 MM. THE LABEL IN THE PACKAGING WAS INCORRECT. THE PHYSICIAN IMPLANTED AN ADDITIONAL LEG EXTENSION TO REACH THE PROPER LENGTH.

  Patient problems: No Code Available

  MAUDE report 5721108 ↗