Zenith Spiral-ZRecalls & reported problems across all models
Cook Incorporated · 29 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 342
- Deaths reported
- 9
- Injuries reported
- 226
- Recalls
- 0
We found 29 models of Zenith Spiral-Z by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 342 adverse event reports in the FDA's MAUDE database, received between Aug 29, 2014 and Oct 10, 2025 — classified as 9 deaths, 226 injuries, 107 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (92 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Zenith Spiral-Z problems
Device problems
- Fluid/Blood Leak92
- Obstruction of Flow55
- Leak/Splash45
- Occlusion Within Device40
- Complete Blockage26
- Partial Blockage23
- Adverse Event Without Identified Device or Use Problem18
- Inadequacy of Device Shape and/or Size11
Patient problems
- No Code Available114
- No Clinical Signs, Symptoms or Conditions39
- Clinical Endoleak36
- No Known Impact Or Consequence To Patient34
- Thrombosis/Thrombus31
- Thrombus24
- Pain23
- Claudication17
Zenith Spiral-Z models
29 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Zenith Spiral-Z G55238SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT42 reports
- Zenith Spiral-Z G55242SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT31 reports
- Zenith Spiral-Z G55237SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT29 reports
- Zenith Spiral-Z G55232SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT3 deaths24 reports
- Zenith Spiral-Z G55243SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT23 reports
- Zenith Spiral-Z G55239SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT3 deaths20 reports
- Zenith Spiral-Z G55241SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT19 reports
- Zenith Spiral-Z G55246SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 death18 reports
- Zenith Spiral-Z G55231SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT17 reports
- Zenith Spiral-Z G55233SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT15 reports
- Zenith Spiral-Z G55234SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT13 reports
- Zenith Spiral-Z G55228SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT12 reports
- Zenith Spiral-Z G55245SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT12 reports
- Zenith Spiral-Z G55247SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT12 reports
- Zenith Spiral-Z G55235SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT11 reports
- Zenith Spiral-Z G55226SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 death6 reports
- Zenith Spiral-Z G55221SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT5 reports
- Zenith Spiral-Z G55236SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT5 reports
- Zenith Spiral-Z G55222SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT4 reports
- Zenith Spiral-Z G55223SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 death4 reports
- Zenith Spiral-Z G55229SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT4 reports
- Zenith Spiral-Z G55225SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT3 reports
- Zenith Spiral-Z G55230SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT3 reports
- Zenith Spiral-Z G55244SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT3 reports
- Zenith Spiral-Z G55227SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 reports
- Zenith Spiral-Z G55240SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 reports
- Zenith Spiral-Z G55219SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- Zenith Spiral-Z G55220SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- Zenith Spiral-Z G55224SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
Recent Zenith Spiral-Z adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryOct 10, 2025Device Endoleak; Device Endoleak
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Clinical Endoleak; Pain
MAUDE report 23270846 ↗InjuryFeb 24, 2025Fluid/Blood Leak; Obstruction of Flow; Device Endoleak; Fluid/Blood Leak; Obstruction of Flow; Device Endoleak
COOK WAS NOTIFIED OF A TYPE IB ENDOLEAK ON A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. THE DISCOVERY WAS MADE IN AN IMAGING REVIEW. THE PATIENT UNDERWENT AN ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE ON AN UNKNOWN DATE. THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2024 WITH ABDOMINAL PAIN. A COMPUTED TOMOGRAPHY (CT) SCAN WAS COMPLETED. THE CT SHOWED A TYPE 1A ENDOLEAK ON THE ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY. THE UNCOVERED SUPRA RENAL FIXATION HAD DETACHED FROM THE GRAFT SEALING STENT. THE GRAFT MIGRATED DISTALLY CONTRIBUTING TO THE LOSS OF THE PROXIMAL SEAL AND RESULTING IN ENLARGEMENT OF THE ANEURYSM SAC. REINTERVENTION WAS PLANNED AND THE PHYSICIAN INQUIRED ABOUT THE PLACEMENT OF A CUFF TO ADDRESS THE ENDOLEAK ON THE ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY. HOWEVER, DETAILS REGARDING THE REINTERVENTION HAVE NOT BEEN PROVIDED AT THE TIME OF THIS REPORT. IMAGING FROM THE EVENT WAS REVIEWED. THE IMAGE REVIEW IDENTIFIED A TYPE 1B ENDOLEAK ON THE RIGHT, IPSILATERAL ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-74-ZT). ADDITIONALLY, MILD PARTIAL THROMBUS WAS PRESENT AT THE LIMB JUNCTIO
Patient problems: Clinical Endoleak; Thrombosis/Thrombus
MAUDE report 21446970 ↗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 ↗InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS EVENT NO LONGER MEETS THE QUALIFICATIONS FOR A REPORTABLE EVENT.
Patient problems: Ischemia
MAUDE report 21200719 ↗InjuryJan 9, 2025Fluid/Blood Leak; Device Endoleak; Fluid/Blood Leak; Device Endoleak
IT WAS REPORTED THAT A TYPE 1B ENDOLEAK WAS IDENTIFIED ON THE LEFT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG DURING A FENESTRATED ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (FEVAR) PROCEDURE ON A 67-YEAR-OLD MALE PATIENT. PRE-PROCEDURE IMAGING WAS COMPLETED ON (B)(6)2024, 112 DAYS PRIOR TO THE PROCEDURE. THE PROXIMAL SEALING ZONE DID NOT HAVE ANY OCCLUSIVE DISEASE OR CALCIFICATION. THROMBUS WAS NOT PRESENT IN THE PROXIMAL SEALING ZONE. THE PROXIMAL SEALING ZONE WAS DESCRIBED AS PARALLEL. THE RIGHT COMMON ILIAC ARTERY, LEFT COMMON ILIAC ARTERY, RIGHT EXTERNAL ILIAC ARTERY, LEFT EXTERNAL ILIAC ARTERY, RIGHT FEMORAL ARTERY, LEFT FORMAL ARTERY DID NOT HAVE ANY CALCIFICATION OR OCCLUSIVE DISEASE. THE ILIAC ARTERIES WERE NOT TORTUOUS. THE AORTA DIAMETER AT THE LOCATION OF THE MAXIMUM ANEURYSM DIAMETER (OUTER-WALL TO OUTER-WALL) WAS 63 MM. THE LENGTH OF THE SUITABLE PROXIMAL SEAL ZONE WAS 50 MM. THE DIAMETER OF THE AORTA AT LOCATION OF MAXIMUM DIAMETER OVER LENGTH OF PROXIMAL SEAL ZONE (OUTER-WALL TO OUTER-WALL) WAS 26 MM. THE DIAMETER OF AORTA AT THE LOCATION OF MINIMUM DIAMETER OVER LENGTH OF PROXIMAL SEAL ZONE (OUTER-WALL TO OUTER-WALL) WAS 24 MM. THE % C
Patient problems: Clinical Endoleak
MAUDE report 21111560 ↗InjuryJan 5, 2025Fluid/Blood Leak; Obstruction of Flow; Device Endoleak; Fluid/Blood Leak; Obstruction of Flow; Device Endoleak
ADDITIONAL INFORMATION WAS PROVIDED ON 24JUL2025 REGARDING THE ADDITIONAL INTERVENTION THAT WAS COMPLETED ON (B)(6) 2025. THE PATIENT'S PRE-OPERATIVE AND POST-OPERATIVE DIAGNOSIS WAS A TYPE 1B ENDOLEAK. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE UNDER GENERAL ENDOTRACHEAL ANESTHESIA ON (B)(6) 2025. NO COMPLICATIONS WERE NOTED IN THE PROCEDURE. THE RADIATION TIME WAS 16 MINUTES. THE RADIATION EXPOSURE WAS 1138 MGY. THE TOTAL PROCEDURE TIME WAS 90 MINUTES. THE CONTRAST VOLUME USED WAS 50 ML. THE INDICATION FOR THE PROCEDURE WAS AN ENLARGEMENT OF THE RIGHT ILIAC ARTERY AND A TYPE 1B ENDOLEAK POST FENESTRATED ENDOVASCULAR REPAIR PROCEDURE IN (B)(6) 2024 WHERE A COOK ZENITH FENESTRATED PLUS GRAFT WAS PLACED IN ADDITION TO COMPETITOR'S STENTS PLACED IN THE CELIAC ARTERY, SUPERIOR MESENTERIC ARTERY, LEFT RENAL ARTERY, AND RIGHT RENAL ARTERY. FOLLOW UP IMAGING COMPLETED ONE YEAR POST OPERATIVE REVEALED ENLARGEMENT OF THE RIGHT ILIAC ARTERY AND A TYPE 1B ENDOLEAK. AT 6 MONTHS POST OPERATIVE MILD DISSECTION AT THE ILIAC BIFURCATION WAS THOUGHT TO BE FROM SHEATH EXCHANGES. OVER THE PAST FEW MONTHS ON SERIAL IMAGING WITH A TYPE 1B ENDOLEAK AND STABLE SAC SIZE, IT WAS DETERMINED THAT THE RIG
Patient problems: Clinical Endoleak; Thrombosis/Thrombus; Vascular Dissection
MAUDE report 21076055 ↗MalfunctionDec 3, 2024Fluid/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 20834036 ↗MalfunctionDec 3, 2024Fluid/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 20834020 ↗InjuryNov 27, 2024Fluid/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 20798275 ↗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 ↗MalfunctionNov 15, 2024Fluid/Blood Leak; Obstruction of Flow; Deformation Due to Compressive Stress; No Apparent Adverse Event; Device Endoleak; Fluid/Blood Leak; Obstruction of Flow; Deformation Due to Compressive Stress; No Apparent Adverse Event; Device Endoleak
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Clinical Endoleak; Thrombosis/Thrombus
MAUDE report 20695015 ↗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 ↗InjuryOct 22, 2024Obstruction of Flow; Obstruction of Flow
ADDITIONAL INFORMATION WAS PROVIDED ON 16DEC2024. THE CUSTOMER INDICATED INITIALLY THERE WAS A RIGHT ILIAC RUPTURE REQUIRING HYPOGASTRIC EMBOLIZATION AND AN ILIAC ENDOCONDUIT. POSTOPERATIVELY AN ILIAC OCCLUSION OCCURRED.
Patient problems: Ischemia; Obstruction/Occlusion; Rupture
MAUDE report 20507483 ↗MalfunctionSep 30, 2024Device-Device Incompatibility; Difficult to Advance; Device-Device Incompatibility; Difficult to Advance
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 20339574 ↗MalfunctionSep 23, 2024Contamination; Device Contaminated During Manufacture or Shipping; Contamination; Device Contaminated During Manufacture or Shipping
THE USED DELIVERY SYSTEM WAS RETURNED TO CINC FOR INVESTIGATION. THE CANNULA WAS RECEIVED BENT IN THE RETURNED PACKAGE. THE TIP OF THE SHEATH OF THE DELIVERY SYSTEM WAS OUT OF ROUND AND UNEVEN. THERE WERE NO SIGNS OF DELAMINATION/FILAMENTS. NO "SPECS" WERE IDENTIFIED IN THE TABLE TOP TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20280546 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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