Zenith Spiral-Z G55228Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10827002552286), received between Aug 29, 2014 and Jun 10, 2024 — classified as 9 injuries, 3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19504802 ↗
• MalfunctionMay 9, 2024Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS DIFFICULT TO ADVANCE DURING A PROCEDURE TO PLACE A STENT EXTENSION IN THE ILIAC ARTERY OF AN 80 YEAR-OLD MALE PATIENT. THE PHYSICIAN PERFORMED SEVERAL TECHNIQUES TO ALLOW ENTRY OF THE DEVICE THROUGH THE PATIENT'S RIGHT VASCULAR ACCESS POINT; HOWEVER, RIGHT COMMON ILIAC STENOSIS MADE ADVANCEMENT OF THE DELIVERY SYSTEM DIFFICULT. THE PHYSICIAN REMOVED THE DEVICE TO VALIDATE THE OPTION OF LEFT ANGIOPLASTY. UPON INSPECTION FOLLOWING DEVICE REMOVAL, IT WAS NOTED THAT THE DILATOR TIP AND CANNULA OF THE DELIVERY SYSTEM WERE DAMAGED. ADDITIONAL MANEUVERS WERE PERFORMED ON THE DEVICE AND THE SYSTEM WAS REINSERTED INTO THE PATIENT'S RIGHT VASCULAR ACCESS. ATTEMPTS WERE MADE TO RELEASE THE ILIAC LEG GRAFT, BUT ALL WERE UNSUCCESSFUL. DUE TO THE DIFFICULTY, THE GRAFT WAS NO LONGER IN THE CORRECT POSITION WITHIN THE DELIVERY SYSTEM. IT WAS THEN DECIDED BY THE PHYSICIAN TO REMOVE THE DELIVERY SYSTEM AND OPEN A NEW LIKE-DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19277501 ↗
• InjuryJul 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TYPE 3B ENDOLEAK WAS IDENTIFIED IN A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG DURING A PROCEDURE TO RELINE AN EXISTING COOK STENT GRAFT IN AN UNKNOWN PATIENT. THE PATIENT UNDERWENT A PROCEDURE TO EXTEND AN EARLIER UNKNOWN COOK STENT GRAFT DUE TO A SUSPECTED TYPE 1B ENDOLEAK. FOLLOWING THE PLACEMENT OF TWO ZSLE ILIAC LEG GRAFTS ON THE RIGHT SIDE, CONTINUED LEAKAGE "TO THE INTERNAL ORGANS" WAS NOTED. IT WAS REPORTED THAT THIS WAS LIKELY DUE TO A TEAR IN THE CLOTH OF THE MOST PROXIMAL ZSLE LEG. THREE STENT GRAFTS FROM ANOTHER MANUFACTURER WERE USED TO SUCCESSFULLY COVER THE LEAK. NO ADDITIONAL HARM TO THE PATIENT HAS BEEN REPORTED AT THIS TIME. THIS REPORT CAPTURES THE TYPE 3B ENDOLEAK DUE TO A TEAR IN THE FABRIC OF THE PROXIMAL ZSLE LEG GRAFT THAT REQUIRED THE PLACEMENT OF THREE ADDITIONAL GRAFTS FROM ANOTHER MANUFACTURER. THE SUSPECTED TYPE 1B ENDOLEAK THAT REQUIRED A RELINE WITH TWO ADDITIONAL ZSLE LEG GRAFTS IS REFERENCED IN A REPORT WITH PATIENT IDENTIFIER: (B)(6). ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT OUTCOME HAVE BEEN REQUESTED BUT ARE CURRENTLY UNAVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 17248784 ↗
• InjuryJan 6, 2020Partial Blockage; Complete Blockage; Partial Blockage; Complete Blockage

  IT WAS REPORTED THAT A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG HAD THROMBOSED IN A PATIENT IN 2015. THE GRAFT WAS IMPLANTED IN AN (B)(6) YEAR OLD MALE PATIENT DURING AN EVAR ON (B)(6) 2015. THIS GRAFT WAS THE RIGHT LIMB, AND 10 MONTHS LATER, IT WAS NOTED THAT IT OCCLUDED. THE PATIENT REQUIRED AN ADDITIONAL SURGERY AND HOSPITALIZATION. A SURGICAL THROMBECTOMY AND ADDITIONAL STENTING OF THE LIMB WAS PERFORMED.

  Patient problems: No Code Available

  MAUDE report 9554136 ↗
• InjuryJul 3, 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 8759750 ↗
• MalfunctionMar 24, 2017Leak/Splash; Leak/Splash

  AN (B)(6) MALE PATIENT UNDERWENT AAA REPAIR. THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR REPAIR. THE IMA WAS COIL EMBOLIZED PRIOR TO PLACING THE STENT GRAFTS. AFTER PLACING BODY AND TWO ILIAC LEG GRAFTS, THE USER DID BALLOONING WITH CODA-2-10.0-35-120-32 AS LABELED. FINAL ANGIOGRAM WAS PERFORMED AND THE PHYSICIAN CONFIRMED JET-LIKE CONTRAST FROM AROUND THE FOURTH STRAT OF THE MAIN BODY (REF #: 1820334-2017-00366). HE THEN PERFORMED ANGIOGRAM INSIDE THE MAIN BODY AND CONFIRMED THE SAME CONTRAST AND SUSPECTED IT WAS TYPE III ENDOLEAK FROM SUTURE HOLE. TO AVOID ENLARGING THE SUTURE HOLE, HE DECIDED NOT TO PERFORM ADDITIONAL BALLOONING AT THE LEAK SITE AND TO TAKE WAIT-AND-SEE APPROACH AND COMPLETED THE PROCEDURE. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2017 STATED THE PHYSICIAN COMMENTED THAT A SLIGHT AMOUNT OF 'LEAK-LIKE' THING WAS CONFIRMED AT A FOLLOW-UP EXAM. HOWEVER, NO HEALTH HAZARD HAS BEEN OCCURRED. ADDITIONAL INFORMATION PROVIDED BY THE IMAGING REVIEW CONDUCTED ON (B)(6) 2017 FOR THE RELATED MEDWATCH 1820334-2017-00366 INDICATED THAT THERE ARE ALSO TYPE 3B ENDOLEAKS ON THE RIGHT LEG (ZSLE-13-56-ZT REFERENCE # 1820334-2017-00632) AND ON THE LEFT LEG (ZSLE-11-

  Patient problems: No Code Available

  MAUDE report 6431980 ↗
• InjuryJan 13, 2017Leak/Splash; Leak/Splash

  ON (B)(6) 2016, AN (B)(6) MALE PATIENT UNDERWENT AAA REPAIR. THE PATIENT'S ANATOMY WAS SUITABLE FOR ENDOVASCULAR REPAIR. THE PHYSICIAN COIL EMBOLIZED THE RIGHT INTERNAL ILIAC ARTERY FIRST AND THEN PLACED THE BIFURCATED MAIN BODY GRAFT (1820334-2017-00013) FOLLOWED BY THE LEFT (1820334-2017-00015) AND RIGHT (1820334-2017-0016) ILIAC LEG GRAFTS AS LABELED. BALLOONING WAS ALSO PERFORMED. BY ANGIOGRAPHY FROM THE NECK SIDE, ENDOLEAK FROM THE RIGHT ABOVE THE LEFT RIM JUNCTION AND FROM BOTH LEGS WAS CONFIRMED. THE PHYSICIAN SUSPECTED IT WAS A TYPE III ENDOLEAK, SO HE PERFORMED ADDITIONAL BALLOONING AT BOTH SIDES' JUNCTION, BUT THE SITUATION WAS NOT CHANGED. THE PHYSICIAN THEN SUSPECTED A TYPE IV ENDOLEAK AND PERFORMED ANGIOGRAPHY IN THE STENT GRAFTS. THE LEAK LOOKED THE SAME AS BEFORE. HE DETERMINED IT WAS EITHER A TYPE IV OR TYPE IIIB ENDOLEAK. IT WAS DECIDED TO TAKE A WAIT-AND-SEE APPROACH AS IT WOULD BE DIFFICULT TO ADD EXTENSIONS IN EITHER TYPE OF ENDOLEAK. NEUTRALIZATION OF THE ANTI-COAGULANT ACTIVITY OF HEPARIN WAS PERFORMED BY ADMINISTRATION OF PROTAMINE AS USUAL. A WEEK AFTER THE PROCEDURE, THE PHYSICIAN CONFIRMED THAT THE ENDOLEAK STILL EXISTED DURING THE FOLLOW-UP CT EXAM. HE CO

  Patient problems: No Code Available

  MAUDE report 6250406 ↗
• InjuryJan 12, 2017Occlusion Within Device; Occlusion Within Device

  ON (B)(6) 2015, UNDER GENERAL ANESTHESIA, THE PATIENT RECEIVED A MAIN-BODY GRAFT, AN IPSILATERAL (RIGHT) ILIAC LEG GRAFT, AND A CONTRALATERAL (LEFT) ILIAC LEG GRAFT. THE DEVICES WERE DEPLOYED AND A MOLDING BALLOON WAS USED WITHOUT COMPLICATIONS OR DIFFICULTIES. NO ANCILLARY COMPONENTS WERE PLACED. A PLANNED RIGHT HYPOGASTRIC ARTERY OCCLUSION PROCEDURE WAS PERFORMED PRIOR TO GRAFT DEPLOYMENT. THERE WERE NO ADVERSE EVENTS OBSERVED DURING THE PROCEDURE. THE COMPLETION ANGIOGRAM DEMONSTRATED THAT THE ENDOVASCULAR GRAFT WAS PATENT WITH NO EVIDENCE OF A KINK OR ENDOLEAKS. CORE LAB ANALYSIS OF THE COMPLETION ANGIOGRAM CONCURRED. THE PATIENT WAS DISCHARGED ON (B)(6) 2015 AND NO ADVERSE EVENTS WERE REPORTED. ON (B)(6) 2015, THE ONE MONTH FOLLOW UP CT SCAN AND X-RAY WERE PERFORMED. THE CORE LAB EVALUATION REVEALED THAT THE DEVICE WAS PATENT AND INTACT WITH NO BARB SEPARATION, STENT FRACTURES, COMPONENT SEPARATION, DEVICE STENOSIS, ENDOLEAKS, OR KINKS. ON (B)(6) 2016, THE SIX MONTH FOLLOW UP CT SCAN AND X-RAY WERE PERFORMED. THE X-RAY REVEALED THAT THE DEVICE WAS INTACT WITH NO BARB SEPARATION, STENT FRACTURES, COMPONENT SEPARATION, MIGRATION, DEVICE STENOSIS OR KINKS. THE CT SCAN REVEALED TH

  Patient problems: No Code Available; Occlusion

  MAUDE report 6246746 ↗
• InjuryJan 11, 2017Occlusion Within Device; Occlusion Within Device

  ON (B)(6) 2015, UNDER GENERAL ANESTHESIA, THE PATIENT RECEIVED A MAIN-BODY GRAFT, AN IPSILATERAL RIGHT ILIAC LEG GRAFT, AND A CONTRALATERAL LEFT ILIAC LEG GRAFT. THE DEVICES WERE DEPLOYED WITHOUT DIFFICULTY. A MOLDING BALLOON WAS USED WITHOUT COMPLICATIONS OR DIFFICULTIES. NO ANCILLARY COMPONENTS WERE PLACED. A PLANNED RIGHT HYPOGASTRIC ARTERY OCCLUSION PROCEDURE WAS PERFORMED PRIOR TO GRAFT DEPLOYMENT. THERE WERE NO ADVERSE EVENTS OBSERVED DURING THE PROCEDURE. THE COMPLETION ANGIOGRAM DEMONSTRATED THAT THE ENDOVASCULAR GRAFT WAS PATENT WITH NO EVIDENCE OF A KINK OR ENDOLEAKS. CORE LAB ANALYSIS OF THE COMPLETION ANGIOGRAM CONCURRED. THE PATIENT WAS DISCHARGED ON (B)(6) 2015 AND NO ADVERSE EVENTS WERE REPORTED. ON (B)(6) 2015, THE ONE-MONTH FOLLOW-UP CT AND X RAY WAS PERFORMED. THE CORE LAB EVALUATION REVEALED THAT THE DEVICE WAS PATENT AND INTACT WITH NO BARB SEPARATION, STENT FRACTURES, COMPONENT SEPARATION, DEVICE STENOSIS OR KINKS. ON (B)(6) 2016, THE SIX MONTH FOLLOW UP CT SCAN AND X-RAY WERE COMPLETED AND SHOWED THAT THE DEVICE WAS INTACT WITH NO BARB SEPARATION, STENT FRACTURES, COMPONENT SEPARATION, MIGRATION, DEVICE STENOSIS, ENDOLEAKS, OR KINKS. THE CORE LAB ANALYSIS OF T

  Patient problems: No Code Available; Occlusion

  MAUDE report 6242391 ↗
• InjuryMay 6, 2016Leak/Splash; Leak/Splash

  DURING A AAA PROCEDURE ON THE (B)(6) YEAR OLD MALE PATIENT, THE LIMB LOOKED AS THOUGH IT WAS LEAKING THROUGHOUT THE FABRIC; TYPE IV ENDOLEAK. THE USER PLACED AN ADDITIONAL LIMB (11 X 90) AND THE ENDOLEAK WAS FIXED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 5637196 ↗
• InjuryMar 20, 2015Leak/Splash

  A PT WITH A PREVIOUSLY PLACED GRAFT (MANUFACTURE UNK), UNDERWENT EVAR REPAIR ON 02/25/2015. THE PREVIOUS PLACED GRAFT HAD DEVELOPED AN ENDOLEAK AND AN ANEURYSM WAS FORMING FROM THE BIFURCATION AND THE RIGHT ILIAC ARTERY, SO THE PHYSICIAN PLACED A RENU MAIN BODY AND A ZENITH ILIAC LEG GRAFT WITH SPIRAL-Z TECHNOLOGY TO RELINE THE PREVIOUS PLACED GRAFTS. DURING THE REPAIR PROCEDURE THERE WAS A TYPE I ENDOLEAK THAT WAS REPAIRED BY PLACING ANOTHER MANUFACTURER'S STENT (1820334-2015-00155). ALSO, ONE OF THE DEVICES EXPERIENCED A VALVE LEAK AND THE PT WAS GIVEN ONE LITER OF BLOOD (1820334-2015-00092). THE PROCEDURE DID LAST LONGER THAN ANTICIPATE.

  Patient problems: Surgical procedure, additional

  MAUDE report 4691992 ↗
• InjuryAug 29, 2014Leak/Splash

  A (B)(6) MALE PATIENT UNDERWENT EVAR ON (B)(6) 2014. THE PHYSICIAN PLACED ZENITH MAIN BODY, CONTRALATERAL, AND IPSILATERAL LEGS AND THEN LIGHTLY BALLOON MOULDED. USING A PIG TAIL CATHETER FOR WHAT WAS PLANNED TO BE THE FINAL ANGIO RUN WAS PERFORMED. THERE APPEARED TO BE A LEAK ON THE RIGHT SIDE. AT FIRST IT WAS FELT IT WAS A TYPE 1B LEAK COMING FROM THE DISTAL END OF THE RIGHT LEG EXTENSION. THE DOCTORS THEREFORE EXTENDED WITH ANOTHER SPIRAL-Z LIMB AND LIGHTLY BALLOON MOULDED. THE DOCTORS THEN DID A RUN IN JUST THE RIGHT LEG BUT THE LEAK PERSISTED AND SEEMED TO BE COMING THROUGH THE FABRIC OF THE SPIRAL SEGMENT OF THE INITIALLY PLACE ILIAC LEG GRAFT. THEREFORE THE DOCTORS RELINED THE SEGMENT WITH ANOTHER ILIAC LEG GRAFT WITH SPIRAL-Z TECHNOLOGY. THE LEAK WAS NOT PRESENT ON THE SUBSEQUENT RUN, AND THE DOCTORS SUSPECTED A TYPE 3 ENDOLEAK. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 4054162 ↗