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Zenith Spiral-Z G55244Recalls & 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 10827002552446), received between Sep 12, 2017 and Aug 17, 2021 — classified as 2 injuries, 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
  • Obstruction of Flow1
  • Partial Blockage1
  • Positioning Failure1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Code Available1
  • No Known Impact Or Consequence To Patient1
  • Obstruction/Occlusion1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 17, 2021Partial Blockage; Obstruction of Flow; Partial Blockage; Obstruction of Flow

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

    MAUDE report 12331965 ↗
  • InjuryMay 6, 2020Fluid/Blood Leak; Fluid/Blood Leak

    IN ADDITIONAL INFORMATION RECEIVED ON 12MAY2020, IT WAS REPORTED THAT THE PATIENT'S SECONDARY PROCEDURE WAS SUCCESSFUL. HE WAS DISCHARGED THE FOLLOWING DAY. NO IMAGING IS AVAILABLE FROM THE CUSTOMER.

    Patient problems: No Code Available

    MAUDE report 10029396 ↗
  • MalfunctionSep 12, 2017Positioning Failure; Positioning Failure

    AS REPORTED BY THE DISTRIBUTOR, DURING AN ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR ON A (B)(6) MALE PATIENT, THE PHYSICIAN WAS UNABLE TO WITHDRAW THE MANDREL FROM THE DELIVERY SYSTEM OF THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG EXTENSION; EVEN AFTER NUMEROUS ATTEMPTS. THIS GRAFT WAS NOT IMPLANTED. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS VERY GOOD. ACCORDING TO THE REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6859170 ↗

Other SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices

All SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices →

Sources and updates

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