Zenith Spiral-Z G55230Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002552309), received between Dec 14, 2018 and Nov 27, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
- Obstruction of Flow1
Patient problems
- Claudication1
- Clinical Endoleak1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionMar 19, 2024Fluid/Blood Leak; Fluid/Blood Leak
COOK WAS NOTIFIED THAT LEAKAGE OCCURRED ON A COOK ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG DELIVERY SYSTEM DURING A FENESTRATED ENDOVASCULAR AORTIC REPAIR (EVAR) THAT REQUIRED A LEG EXTENSION. THE LEAKAGE WAS IDENTIFIED BETWEEN THE "WHITE RING AND THE TRANSLUCENT CHAMBER OF THE CAPTOR VALVE". THE LEAKAGE MADE IT DIFFICULT TO PROPERLY FLUSH THE DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18935431 ↗InjuryDec 14, 2018Obstruction of Flow; Obstruction of Flow
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
Patient problems: Claudication; No Code Available
MAUDE report 8166899 ↗
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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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