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Zenith Renu G55394Recalls & reported problems

Cook Incorporated · Zenith Renu, AAA Ancillary Graft Converter · Class 3 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
1
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002553948), received between Jan 2, 2020 and Jan 2, 2020 — classified as 1 death.

The most frequently reported specific device problem is “Activation Failure” (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 16, 2026.

Most reported problems

Device problems

  • Activation Failure1
  • Difficult or Delayed Activation1

Patient problems

  • Death1
  • Foreign Body In Patient1
  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • DeathJan 2, 2020Difficult or Delayed Activation; Activation Failure; Difficult or Delayed Activation; Activation Failure

    IT WAS REPORTED THAT THE TOP CAP OF A ZENITH RENU AAA ANCILLARY GRAFT CONVERTER DELIVERY SYSTEM WAS UNABLE TO BE PUSHED OFF. DUE TO THE DIFFICULTY, THE DELIVERY SYSTEM WAS LEFT IN THE PATIENT. A (B)(6) YEAR OLD MALE PATIENT UNDERWENT AN AORTO-UNILIAC PROCEDURE VIA THE LEFT SIDE ON (B)(6) 2019. THE RIGHT ILIAC ARTERY WAS UNABLE TO BE USED AS IT WAS COMPLETELY OCCLUDED BY THROMBUS FORMATION. THE 22 FRENCH SHEATH WAS DIFFICULT TO DELIVER INTO THE PATIENT DUE TO TORTUOSITY, AND THE DELIVERY SYSTEM WAS CATCHING ON CALCIFICATION. ONE BARE METAL AND TWO COVERED STENTS WERE DEPLOYED IN THE LEFT ILIAC ARTERY TO DILATE. BALLOONING WAS PERFORMED ALONG THE PATH, AND ABOUT 6 ATTEMPTS WERE NEEDED IN ORDER TO ADVANCE THE DELIVERY SYSTEM INTO PLACE. THE FIRST TWO STENTS OF THE GRAFTS WERE UNSHEATHED WITHOUT ANY ISSUES, AND THE DOCTOR PROCEEDED WITH TOP STENT DEPLOYMENT. THE PROXIMAL TRIGGER WIRE WAS REMOVED WITHOUT ANY ISSUES. A FIRST ATTEMPT WAS MADE TO PUSH OFF THE TOP CAP. IT WAS PUSHED OFF HALF-WAY BEFORE RESISTANCE WAS FELT, AND IT WOULD NOT ADVANCE BEYOND HALF THE BARE STENT WITHOUT PUSHING THE GRAFT PROXIMALLY. MULTIPLE ATTEMPTS WERE PERFORMED AND THE INNER CANNULA BOWED, BUT DIDN'T KINK. I

    Patient problems: Death; Foreign Body In Patient; No Code Available

    MAUDE report 9539821 ↗

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Sources and updates

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