Zenith Spiral-Z G55220Recalls & reported problems
Cook Incorporated · Zenith, Spiral-Z AAA Iliac Leg · Class 3 · Implant
All models of Zenith Spiral-Z (29)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002552200), received between Jun 16, 2022 and Jun 16, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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
Device problems
- Fluid/Blood Leak1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN ENDOLEAK WAS DISCOVERED IN THE DISTAL RIGHT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG IN AN UNKNOWN MALE PATIENT DURING A COMPLEX ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE. NO ISSUES WERE NOTED DURING DEVICE AND BRIDGING STENT IMPLANTATION. THE ZSLE LIMBS WERE IMPLANTED WITHOUT PROBLEMS. A FINAL ANGIOGRAM REVEALED WHAT FIRST APPEARED TO BE A TYPE 1B ENDOLEAK FROM THE DISTAL RIGHT ILIAC LIMB. THE GRAFT AND THE JUNCTIONS BETWEEN THE BIFURCATED AND PROXIMAL COMPONENTS WERE RE-BALLOONED. A 9CM X 5CM GRAFT FROM ANOTHER MANUFACTURER WAS IMPLANTED DISTAL TO THE ZSLE LIMB THAT RESOLVED THE POSSIBLE TYPE 1B ENDOLEAK; HOWEVER, AN ENDOLEAK ORIGINATING FROM THE ZSLE LIMB WAS STILL PRESENT. INTRAVASCULAR ULTRASOUND (IVUS) WITHIN THE RIGHT COMMON ILIAC ARTERY LIMB DID NOT HELP TO DELINEATE THE SOURCE OF THE LEAK. THE PHYSICIAN DECIDED TO RE-LINE THE RIGHT ILIAC LIMB WITH A 10CM X 7CM LIMB FROM ANOTHER MANUFACTURER, WHICH RESOLVED THE ENDOLEAK. THE PATIENT LEFT THE OPERATING ROOM (OR) IN GOOD CONDITION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT DETAILS HAVE BEE
Patient problems: Failure of Implant
MAUDE report 14711515 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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