Zenith Spiral-Z G55224Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002552248), received between Dec 6, 2017 and Dec 6, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Occlusion Within Device” (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
- Occlusion Within Device1
Patient problems
- Claudication1
- Stenosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 6, 2017Occlusion Within Device; Occlusion Within Device
THE AREA REPRESENTATIVE REPORTED THAT A MALE PATIENT WITH AN ABDOMINAL AORTIC ANEURYSM (AAA) AND COMMON ILIAC ARTERY (CIA) ANEURYSM HAD A STAND-ALONE COOK ILIAC SIDE BRANCH (IBD) IMPLANTED IN 2009. IT IS BELIEVED A LEFT COMMON ILIAC ARTERY (LCIA) COVERED STENT WAS ALSO IMPLANTED AND DOCTOR ASSUMES IT IS SELF-EXPANDING. IN 2013, AN AAA REPAIR WAS PERFORMED USING THE FOLLOWING COMPONENTS, A ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY (INTRO FROM RIGHT SIDE). A RIGHT BRIDGING LEG USING A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG BRIDGING FROM THE CONTRALATERAL TROUSER LEG INTO THE IN SITU LCIA STENT. A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG ON THE LEFT SIDE EXTENDING ALL THE WAY UP TO THE CONTRALATERAL TROUSER LEG; WHICH MEANS THERE ARE THREE FABRIC LAYERS AT THIS POINT. THE PATIENT HAS FELT AN INCREASE IN BUTTOCK CLAUDICATION, AND ULTRASOUND HAS SHOWN UP TO 75% STENOSIS THROUGH THE GRAFT LIMBS. THE DOCTOR ORDERED A COMPUTERIZED TOMOGRAPHIC ANGIOGRAPHY (CTA) AND BOOKED THE PATIENT FOR SURGERY. ON (B)(6) 2017, AFTER GAINING ACCESS, THE DOCTOR USED
Patient problems: Claudication; Stenosis
MAUDE report 7088627 ↗
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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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