Skip to content

Zenith Spiral-Z G55227Recalls & 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
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002552279), received between Dec 27, 2016 and Jan 4, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Hole In Material” (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

  • Hole In Material1
  • Inadequacy of Device Shape and/or Size1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Code Available1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 4, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    IT WAS REPORTED THAT A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG APPEARED TO BE 7MM SHORT DURING A FENESTRATED AAA REPAIR PROCEDURE. THE LENGTH OF THE COMMON ILIAC ARTERY WAS MEASURED WITH A PIGTAIL. X-RAY IMAGING REVEALED THAT THE LENGTH OF THE GRAFT WAS "COMING UP TOO SHORT" INTRAOPERATIVELY BY 7MM. THE DEVICE WAS REMOVED AND A LONGER DEVICE WAS IMPLANTED SUCCESSFULLY TO COMPLETE THE PROCEDURE. FOLLOWING SURGERY, THE GRAFT WAS MEASURED OUTSIDE OF THE PATIENT AT 105MM. IT WAS ALSO REPORTED THAT THE PHYSICIAN WAS NOT CONFIDENT THAT THE GRAFT WOULD MAKE UP THE DIFFERENCE IN LENGTH. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

    MAUDE report 11109538 ↗
  • InjuryDec 27, 2016Hole In Material; Hole In Material

    DURING REPAIR OF A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, A HOLE IN THE GRAFT WAS NOTED, BALLOONED AND ANOTHER MANUFACTURER'S PLUG WAS PLACED IN THE RIGHT SIDE. AFTERWARDS, THE PHYSICIAN NOTED THE HOLE WAS STILL PRESENT PER IMAGING. A SECOND GRAFT, WAS PLACED TO RE-ALIGN.

    Patient problems: No Code Available

    MAUDE report 6204912 ↗

Other SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices

All SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page