Zenith Spiral-Z G55231Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10827002552316), received between Mar 11, 2015 and Jan 21, 2025 — classified as 9 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT NO LONGER MEETS THE CRITERIA OF A REPORTABLE COMPLAINT. PLEASE SEE H11.

  Patient problems: Ischemia

  MAUDE report 21200781 ↗
• MalfunctionNov 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A TYPE 1B ENDOLEAK WAS NOTED ON A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-13-56-ZT) DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) FOR AN UNKNOWN PATIENT ON (B)(6)2024. A COOK REPRESENTATIVE WAS PRESENT DURING THE EVAR PROCEDURE BUT WAS NOT INCLUDING IN THE SIZING AND PLANNING PROCESS FOR THE GRAFT. UPON DEPLOYMENT OF THE LEFT (CONTRALATERAL) LIMB, IT WAS NOTED THAT THE ILIAC LOOKED TO BE OF A LARGER CALIBER; HOWEVER, THE CLINICAL TEAM FELT THE 13MM LIMB WOULD SEAL IN THE SHORT COMMON ILIAC. THE DEVICE WAS DEPLOYED ACCURATELY TO THE LEFT INTERNAL ILIAC OSTIUM, AND THE CASE COMPLETED WITH BALLOON MOLDING OF THE OVERLAPS AND SEAL ZONES. IT WAS THEN NOTED DURING THE COMPLETION ANGIOGRAM, THAT A SIGNIFICANT TYPE 1B ENDOLEAK WAS PRESENT WITH CONTRAST VISIBLE OUTSIDE THE SEAL OF THE CONTRALATERAL LIMB. A CODA BALLOON WAS REINTRODUCED AND INFLATED FOR AN ELONGATED PERIOD OF TIME, AND THE LEAK APPEARED TO SLOW. THE ANESTHESIA TEAM HAD RECENTLY ADMINISTERED AN ADDITIONAL 2000 IU OF HEPARIN, AND THE ACT WAS 195. THE CLINICAL TEAM FELT WITH THE SLOWING OF THE ENDO LEAK AND HEPARIN LOAD, THEY WOULD ALLOW THE GRAFT TO SETTLE FOR FOLLOW UP AT A LATER DATE,

  Patient problems: Clinical Endoleak

  MAUDE report 20737481 ↗
• InjuryNov 14, 2024Obstruction of Flow; Obstruction of Flow

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

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20688981 ↗
• InjuryJul 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TYPE 3 ENDOLEAK WAS IDENTIFIED IN A (B)(6) PATIENT THAT HAD A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG IMPLANTED. THE THEN (B)(6) PATIENT WAS DIAGNOSED WITH AN INFRA-RENAL ABDOMINAL AORTIC ANEURYSM (DIAMETER: 6.7X 6.4CM, LENGTH: 6.7X 6.4CM) AND UNDERWENT AN ENDOVASCULAR ABDOMINAL AORTIC REPAIR (EVAR) PROCEDURE ON 04MAY2013, IN WHICH THE FOLLOWING DEVICES WERE IMPLANTED: COOK ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY RPN: TFFB-28-96-ZT, LOT: 3812613. COOK ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG RPN: ZSLE-13-56-ZT, LOT: 3984758 (IPSILATERAL ILIAC LEG). COOK ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG RPN: ZSLE-16-90-ZT, LOT: 3781834 (CONTRALATERAL ILIAC LEG). DURING THE INDEX PROCEDURE, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA IN THE SUPINE POSITION. SKIN INCISIONS WERE MADE ON BOTH GROINS AND AN APPROACH WAS MADE TO THE FEMORAL ARTERY. THE GUIDE WAS INSERTED UNDER FLUOROSCOPY, THE PLASTIC SHEATH WAS INSERTED, AND CONTRAST MEDIA WAS INJECTED, THE MAIN BODY GRAFT (TFFB-28-96-ZT) WAS INSERTED INTO THE LEFT GROIN, FOLLOWED BY THE EXTENSION ILIAC LEGS (ZSLE-13-

  Patient problems: Clinical Endoleak

  MAUDE report 17334471 ↗
• InjuryOct 1, 2022Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN INDICATED THAT OVER THE PAST FEW YEARS SHE HAS HAD PATIENTS EXPERIENCE LIMB OCCLUSIONS A YEAR OR TWO AFTER IMPLANT. PATIENT SPECIFIC INFORMATION WAS PROVIDED. THE PATIENT RECEIVED THE FOLLOWING COOK DEVICES DURING AN ENDOVASCULAR AORTIC REPAIR (EVAR) PM (B)(6) 2016. ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY (RPN: ZALB-24-118, LOT 6660543). ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-13-74-ZT, LOT 6656102).(B)(6) ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN:ZSLE-13-56-ZT, LOT 6664308). THE SURGEON IDENTIFIED A LIMB OCCLUSION IN A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG 1-2 YEARS LATER. IT IS UNKNOWN WHICH ILIAC LEG GRAFT OCCLUDED. THE PATIENT UNDERWENT A FEMORAL TO FEMORAL CROSSOVER REPAIR ON (B)(6) 2021. THE PHYSICIAN INDICATED THAT THEY ARE UNWILLING TO ANSWER ANY FURTHER REQUESTS FOR ADDITIONAL INFORMATION RELATED TO THIS EVENT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15523203 ↗
• MalfunctionJan 4, 2021Partial Blockage; Partial Blockage

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11109281 ↗
• MalfunctionOct 26, 2020Fluid/Blood Leak; Fluid/Blood Leak

  UPON IMAGE REVIEW AND INVESTIGATION OF ANOTHER EVENT COMPLAINT, A LIMITED TYPE 1B ENDOLEAK WAS FOUND AT THE DISTAL RIGHT ZSLE LEG GRAFT AT 51 MONTHS POSTOP. ON (B)(6) 2015, UNDER GENERAL ANESTHESIA, THE (B)(6) PATIENT UNDERWENT PLACEMENT OF A THREE-PIECE AAA ENDOVASCULAR GRAFT. A 28 MM X 118 MM MAIN BODY COMPONENT NOT SOLD IN THE US, A 13 MM X 56 MM IPSILATERAL (RIGHT) ILIAC LEG GRAFT (SUBJECT OF THIS COMPLAINT), AND A 13 MM X 56 MM CONTRALATERAL (LEFT) ILIAC LEG GRAFT WERE DEPLOYED. THE PROXIMAL EDGE OF THE GRAFT MATERIAL WAS DEPLOYED BETWEEN THE RENAL ARTERIES. A COOK MOLDING BALLOON, WAS USED DURING THE PROCEDURE WITHOUT DIFFICULTY OR COMPLICATIONS. ADDITIONAL NON-ZENITH KISSING BALLOONS (PROXIMAL/ILIAC) WERE USED DURING THE PROCEDURE. THE COMPLETION ANGIOGRAM DEMONSTRATED THAT THE ENDOVASCULAR GRAFT WAS PATENT WITH NO EVIDENCE OF A KINK. A TYPE II ENDOLEAK WAS NOTED (LOCATION NOT PROVIDED). CORE LAB ANALYSIS OF THE COMPLETION ANGIOGRAM NOTED A PATENT GRAFT WITH NO EVIDENCE OF A KINK OR ENDOLEAK. THE PATIENT¿S ESTIMATED BLOOD LOSS WAS 350 CC AND NO BLOOD PRODUCTS WERE GIVEN INTRA-OPERATIVELY. NO PATIENT-RELATED ADVERSE EVENTS WERE OBSERVED DURING THE PROCEDURE. ON (B)(6) 2015 (O

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10736464 ↗
• 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 10567447 ↗
• InjuryAug 18, 2020Partial Blockage; Partial Blockage

  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 10421113 ↗
• InjuryJun 4, 2020Complete Blockage; Complete Blockage

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

  Patient problems: No Code Available

  MAUDE report 10120236 ↗
• InjuryOct 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION REGARDING EVENT DETAILS WAS UPDATED BY THE STUDY SITE AND RECEIVED ON 2019. ON (B)(6) 2019, THE PATIENT HAD A SUCCESSFUL SECONDARY INTERVENTION TO TREAT THE TYPE 1B ENDOLEAK ON BOTH THE RIGHT AND LEFT ILIAC LEGS. IN THE INTERVENTION, ANCILLARY COMPONENTS (TWO STENT EXCLUDERS) WERE PLACED AS BILATERAL ILIAC EXTENSIONS. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2019 TO (B)(6) 2019. REGARDING THE INITIAL SOURCE FOR NEEDING THE REQUIRED INTERVENTION, THE STUDY SITE COMMENTED "MIGRATION OF DEVICES CAUSED BY AGGRAVATION OF THE AAA".

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 9191789 ↗
• InjuryMar 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO NEW EVENT INFORMATION TO REPORT.

  Patient problems: No Code Available

  MAUDE report 8465858 ↗
• MalfunctionFeb 26, 2019Leak/Splash; Leak/Splash

  THERE HAS BEEN NO NEW EVENT INFORMATION RECEIVED SINCE THE LAST REPORT WAS FILED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8371257 ↗
• InjuryJul 27, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR PROCEDURE WITH A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. THE PATIENT REPORTED A LIMB OCCLUSION TO HIS LEFT SIDE APPROXIMATELY 2 WEEKS POST INITIAL IMPLANTATION. THIS PATIENT HAD X 2 ZSLE'S IMPLANTED ON THE LEFT SIDE WHICH WAS VERY TORTUOUS. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT WILL REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE, THE PHYSICIAN PLANS TO DO A FEM-FEM CROSSOVER GRAFT FOR THIS PATIENT DUE TO THE OCCLUSION.

  Patient problems: Occlusion

  MAUDE report 6747823 ↗
• MalfunctionJul 17, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PREPARATION OF THE DEVICE FOR THE PROCEDURE, THE HEMOSTATIC VALVE WAS NOTED TO BE LEAKING SALINE SOLUTION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THIS EVENT OCCURRED PRIOR TO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6717808 ↗
• MalfunctionMar 24, 2017Leak/Splash; Leak/Splash

  AN (B)(6) YEAR OLD 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; (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 (RELATED REFERENCE # 1820334-2017-00366) INDICATED THAT THERE ARE ALSO TYPE 3B ENDOLEAKS ON THE RIGHT LEG (THIS REPORT 1820334-2017-00632) AND ON THE LEFT LEG (REF # 1820334-2017-006

  Patient problems: No Code Available

  MAUDE report 6431525 ↗
• MalfunctionMar 11, 2015Difficult to Advance

  THE PT WAS TREATED WITH BILATERAL PERCUTANEOUS APPROACH. THE 8 FRENCH SHEATHS WERE PLACED AND THE AMPLATZ EXTRA STIFF WIRE PLACED. THE FLUSH CATH WAS PLACED ON THE LEFT SIDE AND A COMPLETE AORTIC ANGIOGRAM WAS OBTAINED. DURING MAIN BODY PREP, THE BLACK STYLET WAS VERY DIFFICULT TO REMOVE. HEMOSTATS WERE USED TO REMOVE STYLET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 4605871 ↗